Pharmaceutical and Formulation

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LC DETERMINATION OF DEFERASIROX IN PHARMACEUTICAL FORMULATION

LC DETERMINATION OF DEFERASIROX IN PHARMACEUTICAL FORMULATION

An isocratic reverse phase liquid chromatography (RP-LC) method has been developed and subsequently validated for the determination of Deferasirox in pharmaceutical formulation. Separation was achieved with a Develosil ODS HG-5 (150 mmx4.6 mm I.D; particle size 5 μm) and Sodium dihydrogen phosphate monohydrate Buffer (pH adjusted to 3.0 with dilute orthophosphoric acid): Acetonitrile (55:45) as eluent at flow rate 2.0 mL/min. UV detection was performed at 245nm. The method is simple, rapid, and selective. The described method of Deferasirox is linear over a range of 11.999 μg/mL was 35.997 μg/mL. The method precision for the determination of assay was below 2.0%RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 100.5 to 101.0. The method is useful in the quality control of pharmaceutical formulations.
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DEVELOPMENT AND VALIDATION OF DUAL WAVELENGTH SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF OFLOXACIN AND PREDNISOLONE ACETATE IN PHARMACEUTICAL FORMULATION

DEVELOPMENT AND VALIDATION OF DUAL WAVELENGTH SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF OFLOXACIN AND PREDNISOLONE ACETATE IN PHARMACEUTICAL FORMULATION

The present manuscript describes simple, sensitive, rapid, accurate, precise and economic dual wavelength method for simultaneous estimation of Ofloxacin and Prednisolone acetate in pharmaceutical formulation. The principle of dual wavelength method is “the absorbance difference between two points on the mixture spectra is directly proportional to the concentration of the component of interest”. Ofloxacin was determined directly at 323.40 nm in methanol. The wavelengths selected for determination of Prednisolone acetate were 323.40 nm and 277 nm in methanol. The two drugs follow Beer- Lambert’s law over the concentration range of 3-40 μg/ml. The method was successfully applied to pharmaceutical formulation. The suitability of this method for the quantitative determination of Ofloxacin and Prednisolone acetate was proved by validation. The results of analysis have been validated statistically and by recovery studies according to ICH guidelines.
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Stability indicating RP-HPLC method for simultaneous determination of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation: Application to method validation

Stability indicating RP-HPLC method for simultaneous determination of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation: Application to method validation

The present work takes into account the development of Reverse Phase High Performance Liquid Chromatography (HPLC) for simultaneous method estimation and validation of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation. The chromatographic separation was accomplished on C8 column by using acetonitrile and potassium dihydrogen phosphate as the mobile phase (60:40 v/v) having a flow rate of 0.8 ml/minute. The eluent was detected at 254 nm, simultaneously for both the drugs. The retention time for pyrimethamine and sulfamethoxypyrazine was found to be 3.33 and 4.21 minutes, respectively. According to the International Conference on Harmonisation guidelines, the develop method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, robustness, and stress degradation studies. This validated method can be suggested for the routine simultaneous laboratory analysis of pyrimethamine and sulfamethoxypyrazine.
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Development and Validation of a RP-HPLC Method for Simultaneous Determination of Betamethasone and Sodium Benzoate in Oral Liquid Pharmaceutical Formulation

Development and Validation of a RP-HPLC Method for Simultaneous Determination of Betamethasone and Sodium Benzoate in Oral Liquid Pharmaceutical Formulation

The present work reports development and validation of a high-performance liquid chromatography diode array detection procedure for the determination of betamethasone and sodium benzoate in pharmaceutical formulation. Effective chromatographic separation of betamethasone and sodium benzoate was achieved using Nova-pack-C18 (150×3.9 mm, 4 µm) column with gradient elution of the mobile phase composed of 50 mM monobasic potassium phosphate buffer (pH 2.9) and acetonitrile. The elution was a three step gradient elution program with 25% acetonitrile and 75% buffer at 0 min further acetonitrile concentration changed linearly to 45% up to 25 min, followed by changing acetonitrile to 25% up to 35 min. The correlation coefficient for betamethasone and sodium benzoate were 0.9999 and 0.9999, respectively. The developed method was statistically validated with regard to specificity, linearity, accuracy (recovery) and precision.
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Development and validation of a stability-indicating reverse-phase ultra-performance liquid chromatography method for the simultaneous determination of netarsudil and latanoprost in bulk and pharmaceutical formulation

Development and validation of a stability-indicating reverse-phase ultra-performance liquid chromatography method for the simultaneous determination of netarsudil and latanoprost in bulk and pharmaceutical formulation

Objective: A new sensitive and simple stability-indicating reverse-phase ultra-performance liquid chromatography (RP-UPLC) method for the simultaneous estimation of netarsudil (NT) and latanoprost (LT) in bulk and pharmaceutical formulation. Materials and Methods: Chromatographic separation was achieved through BEH C18 column (50 mm × 2.8 mm i.d × 1.8 µm particle size) using water: methanol (70:30 v/v) mixture used as the mobile phase. The water ACQUITY Model UPLC system with TUV detector and EMPOWER version 2.0 software was monitored at detection wave length 220 nm on isocratic mode with flow rate 0.3 ml/min and the method was validated as per ICH guidelines. Results and Discussion: By applying the proposed method, the retention times of NT and LT were found to be 1.448 and 1.868 min, respectively, and the peak shapes were good. The resolution was found to be 3.8, which indicate good separation between the drug peaks. Quantitative linearity was obeyed in the concentration range of 2.5–15 μg/mL for NT and 0.625–3.75 µg/ml for latanoprost. The proposed stability-indicating RP-UPLC method has been developed and validated and found to be simple, specific, accurate, precise, and less time consuming. Conclusion: This method was successfully applied for the determination of NT and LT in their pharmaceutical formulation and hence can be used for the routine analysis of these drugs in combined dosage form. Keywords: ICH guidelines, netarsudil and latanoprost, reverse-phase ultra-performance liquid chromatography, validation
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“Determination of Bio active and Pharmaceutical Components of Chloroform Extract of a Herbal Formulation Nalla Marunthu by GC – MS Analysis” by S.Selvakumar, U. Madhan Kumar, A. Prashanth, J. Sindhuja, Barnali Sarkar, India.

“Determination of Bio active and Pharmaceutical Components of Chloroform Extract of a Herbal Formulation Nalla Marunthu by GC – MS Analysis” by S.Selvakumar, U. Madhan Kumar, A. Prashanth, J. Sindhuja, Barnali Sarkar, India.

The objective of this study to determine the bio active and pharmaceutical components of the Chloroform extract of a poly herbal formulation Nalla Marunthu. The phytoconstituents of Chloroform extract of a poly herbal formulation of Nalla marunthu were analysed by GC-MS. Our results indicate that the presence of 48 phyto constituents of a poly herbal formulation of Nalla marunthu. Medicinal plants have been exhaustively studied for their potential value as a source of drugs. Obviously natural products will continue to be extremely important as sources of medicinal agents.
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NEW VALIDATED STABILITY INDICATING RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND VALSARTAN IN PHARMACEUTICAL FORMULATION

NEW VALIDATED STABILITY INDICATING RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND VALSARTAN IN PHARMACEUTICAL FORMULATION

Various analytical methods were reported for simultaneous estimation of Amlodipine besylate and Valsartan in pure drug, pharmaceutical formulations and biological fluids by spectro- photometric 43-44 , HPLC 45-56 and HPTLC 57 . From the reported RP-HPLC method for the simultaneous estimation of both drugs in pharmaceutical formulation, six methods are stability indicating one but the developed methods have has low linearity range, high flow rate, and mobile phase composition is complex.

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“DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE DETERMINATION OF DAPOXETINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION USING AN EXPERIMENTAL DESIGN” by Pratik Mehta*, Ujjwal Sahoo, Dr. A. K. Seth, India.

“DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE DETERMINATION OF DAPOXETINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION USING AN EXPERIMENTAL DESIGN” by Pratik Mehta*, Ujjwal Sahoo, Dr. A. K. Seth, India.

A rapid and sensitive RP-HPLC method with UV detection (230 nm) for routine analysis of Dapoxetine HCl in a pharmaceutical formulation (Priligy ® ) was developed. Chromatography was performed with mobile phase containing a mixture of buffer [Tri-ethyl amine, pH-4.0 (adjusted with o-phosphoric acid)] and acetonitrile (60:40, v/v) with flow rate was 1.0ml min -1 . The procedure was validated for linearity (correlation coefficient=0.9998), accuracy, robustness and intermediated precision. Experimental design was used for validation of robustness and intermediate results in a decrease of the drug found concentration, while the percentage of organic modifier and pH have no important effect on the response. For intermediate precision measure the variables considered were: analyst, equipment and number of days. The R.S.D. value (0.5%, n=6) indicated a good precision of the analytical method. The proposed method was simple, highly sensitive, precise and accurate and retention time less than 5min indicating that the method is useful for routine quality control.
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DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF RILPIVIRINE IN BULK AND PHARMACEUTICAL FORMULATION

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF RILPIVIRINE IN BULK AND PHARMACEUTICAL FORMULATION

ABSTRACT: In the present research work, four simple, precise, accurate and economical methods of UV spectroscopy have been developed for the estimation of Rilpivirine in bulk and pharmaceutical formulation. Method A involves estimation of Rilpivirine using low cost solvent, 0.01N HCl by zero order spectroscopy at an absorption maximum of 280nm. Method B involves Area under Curve method which involved calculation of integrated value of absorbance with respect to wavelength between two wavelengths selected, 275nm and 285nm respectively. Method C involves first order derivative technique for the same at 264nm. Method D involves second order derivative technique for the same at 237nm. The developed methods were found to be linear in the concentration range of 0.5-7.5μg/mL with correlation coefficient (R 2 ) of 0.9998. The mean percentage label claim of tablets of Rilpivirine estimated by proposed methods was within the acceptable range. The developed methods were validated by following the analytical performance parameters suggested by ICH. All the validation parameters were within the acceptable range. As economical solvent is used, these methods can be used for routine analysis of Rilpivirine in bulk and pharmaceutical formulation.
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CHITOSAN: A NOVEL EXCIPIENT IN PHARMACEUTICAL FORMULATION: A REVIEW

CHITOSAN: A NOVEL EXCIPIENT IN PHARMACEUTICAL FORMULATION: A REVIEW

Chitosan is a cationic natural polysaccharide which is derived from the chitin of crustaceans, with crabs and shrimp-shell wastes as its principal source. Its properties includes extent of deacetylation and the average molecular weight of polymer as well as low toxicity and good bioavailability make it a novel excipient in pharmaceutical formulation as a relatively new development. Together with chitin, chitosan is well thought-out the second most abundant polysaccharide subsequent to cellulose. But in contrast to cellulose, the application of Chitosan in pharmaceutical field is a pretty new development. Recently there are so many formulation were prepared and evaluated within different dosage forms such as ophthalmic, nasal sublingual, buccal, periodontal, gastrointestinal, colon specific, vaginal, transdermal as well as gene carrier which is based on the application of chitosan and its derivatives. Chitosan is biocompatible and show the activities such as antimicrobial and antifungal activities, which makes it a favourable option for biomedical applications. It has been proven to be useful in tissue growth, in tissue repair and accelerating wound-healing and bone regeneration. Microcrystalline chitosan (MCCh) is a highly crystalline grade of chitosan base may be particularly valuable as an excipient. Mucoadhesive tendency of chitosan might also depend on its crystallinity. Efficient gel formation by MCCh could result in substantial mucoadhesion, at least as far as “adhesion by hydration” is concerned. The objective of this review is to summarized the application and formulation based on the chitosan and its derivatives and also to elaborate the importance of chitosan in pharmaceutical field.
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PHARMACEUTICAL STANDARDIZATION OF ANTI EOSINOPHILIC AYURVEDIC FORMULATION - AQUEOUS EXTRACTS OF HEDYCHIUM SPICATUM [HAM.EX SMITH], SASSUREA LAPPA [C.B.CLARKE], EMBLICA OFFICINALIS [GAERTN] AND CURCUMA LONGA [LINN]

PHARMACEUTICAL STANDARDIZATION OF ANTI EOSINOPHILIC AYURVEDIC FORMULATION - AQUEOUS EXTRACTS OF HEDYCHIUM SPICATUM [HAM.EX SMITH], SASSUREA LAPPA [C.B.CLARKE], EMBLICA OFFICINALIS [GAERTN] AND CURCUMA LONGA [LINN]

Pharmaceutical standardisation: Anti eosinophilic herbal formulation – capsulation. Water extracts of the Hedychium spicatum (DPB No: L10060516), Sassurea lappa (DP Batch Number: L 10060517), Emblica officinalis (DP B.NO: L 10060518), Curcuma longa (DP Batch Number: L 10060519) were obtained from Laila inpex Vijayawada and Formulation (Batch No: MIS_16) were homogenized to fine powder and used for pharmaceutical capsulation at IMIS pharmaceutical, Vijayawada.

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Validated Spectrophotometric method for estimation of Paclitaxel in Bulk and Pharmaceutical Formulation

Validated Spectrophotometric method for estimation of Paclitaxel in Bulk and Pharmaceutical Formulation

A simple, precise, rapid UV method has been developed for the determination of Paclitaxel in bulk and its pharmaceutical dosage form. Paclitaxel is a mitotic inhibitor used in cancer chemotherapy. Paclitaxel is used to treat patients with lung, ovarian, breast, head and neck cancer, and advanced forms of Kaposi's sarcoma. Various methods for analysis of same are available but are time consuming and expensive. Here we have developed new, precise, simple spectrophotometric method for estimation of Paclitaxel from bulk. Medium prepared were selected phosphate buffer PH 10. It showed absorption maxima at 230 nm.This method were validated according to ICH guidelines. The drug obeyed Beers law and showed good correlation. The linearity was observed between 5-55 μg/mL . There was no significant difference in the intraday and interday analysis of Paclitaxel determined. The results of analysis were validated with respect to recovery, linearity; Limit of detection and limit of quantitation were found to be satisfactory.
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Preference for pharmaceutical formulation and treatment process attributes

Preference for pharmaceutical formulation and treatment process attributes

The aim of this literature review was to identify and examine published studies presenting preferences for pharmaceutical treatment process attributes. To facilitate synthesis of findings across studies, this review focused only on studies using formal preference assessment meth- odologies that provide a quantitative estimate of the value of treatment process attributes. Findings from these studies should have direct relevance to researchers working in drug development because results can provide insight into the value that patients place on treatment process attributes. Results may also aid clinicians in selecting treatments with attributes that have the potential to enhance treatment adherence.
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UV Spectrophotometric estimation of Diacerein in pharmaceutical formulation

UV Spectrophotometric estimation of Diacerein in pharmaceutical formulation

Three simple, precise and economical UV methods have been developed for the estimation of Diacerein in Pharmaceutical Formulations. Diacerein has the maximum absorbance at 256.2 nm in zero order spectra formed the basis for method A while first order derivative spectrum showed peak at 250.0 nm when n = 1 for method b and method C applied was Area under Curve (AUC) in wavelength range of 262.0-250.0 nm.. Method A utilises A1%, 1cm value at λ max for its analysis. Calibration curve (Regression equation) was used for method B and C for analysis of Diacerein respectively. Drug was found to obey the Beer-Lambert’s law in the concentration range of 5-30µg/mL in all three proposed methods. Results of the analysis were validated statistically and by recovery studies. Results were found to be satisfactory and can be adopted for routine analysis of the drug.
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Estimation of olopatadine hydrochloride by RP–HPLC and U.V spectrophotometry  method in pure and pharmaceutical formulation

Estimation of olopatadine hydrochloride by RP–HPLC and U.V spectrophotometry method in pure and pharmaceutical formulation

detection at 254 nm. The method was linear over a concentration range of 10 – 250μg/. The retention time of 2.857min. Results of analysis were validated statistically and by recovery studies. The mean recovery was 98.2 to101.5. The limit of detection (LOD) and the limit of quantification (LOQ) were found to be 0.024 and 0.075μg/ml. The %RSD for the method precision was found to be less than 2%. To develop simple and economical UV spectrophotometric method for the estimation of Olopatadine in pharmaceutical dosage form available in the market for conjunctivitis.The method was validated as per the ICH guidelines and the results were statistically validated. Linearity was observed in concentration range of 10-60μg/ml for Olopatadine. The accuracy of the method was evaluated by recovery studies and good recovery results were obtained between 98% to 100% and the relative standard deviation was found to be below 2% . A simple, accurate, sensitive and economical UV-spectrophotometric method for the estimation of Olopatadine pharmaceutical dosage form has been developed which can be employed in the industry for the routine analysis.
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Spectrophotometric determination and spectroscopic studies on Schiff base and charge transfer complex of ketorolac tromethamine

Spectrophotometric determination and spectroscopic studies on Schiff base and charge transfer complex of ketorolac tromethamine

The proposed analytical methods for the determination of KT in pure form and pharmaceutical formulation proved to be simple, accurate, and precise compared to the previously reported methods. The assay is rapid and requires simple sample preparation and economical since it depends on the commercially available labora- tory instruments and low consumption of readily avail- able inexpensive reagents. Furthermore, the excipients present in the formulations gave minimal interference with the proposed assay. These advantages permit the successful evaluation of these methods in pharmaceut- ical quality control, and so, it can be routinely applied to the pharmaceutical sample without prior treatment in the determination of KT in bulk and dosage forms. The formation of solid reaction products of KT is confirmed by FT-IR and 1 H NMR, and features of surface morph- ology are investigated by scanning electron microscopy.
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*B. Vijay Kumar, Ch. Vidyadhari, G. Sravan kumar, OV. Harikiran, T. Tanuja, S. Aneela, Somnath De

*B. Vijay Kumar, Ch. Vidyadhari, G. Sravan kumar, OV. Harikiran, T. Tanuja, S. Aneela, Somnath De

HPLC separation of Lamivudine was carried out on a Xterra C18 column by an isocratic elution with methanol-HPLC water (50:50 v/v). The flow rate was constant at 0.6 ml/min and the column temperature was at room temperature (24±1°). The UV wavelength was set at 270 nm. No interference from diluents, impurities, or excipients present in the pharmaceutical formulation was observed at this detection wavelength. Before each run LC column was equilibrated with the mobile phase for about 15 min. A sharp, symmetrical peak was obtained for Lamivudine when analyzed under these conditions a. This retention time enable rapid determination of the drug, which is important for routine quality control analysis.
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AYURVEDIC NATURAL EXCIPIENTS: AN ADVANCE OPTION FOR MODERN MEDICAMENTS

AYURVEDIC NATURAL EXCIPIENTS: AN ADVANCE OPTION FOR MODERN MEDICAMENTS

In few Ayurvedic dosages trijatak, chaturjatak, manjistha etc are used as flavoring agent according to need of patients i.e. in case pediatric preparation these may be added for better palatability so that child can take it easily e.g Avaleha, syrup etc. In sandhan Kalpna (biomedical fermented formulation), alcoholic substances are formed during their pharmaceutical processing and these are responsible for better absorption of medicament and may also act as preservative 24 . Overall it is observed that these formulations are designed in such a manner that some ingredients play major role as per disease condition, some may potentiate the action of main drugs, some act as drug delivery system and ingredients may also interact to each other to nullify to adverse effect of other and finally produce beneficial effect to mankind. After comprehensive analysis of literature in Ayurveda, we found that there are many ingredients that can be called as probable excipient (Table 1 and 2). Most of time during metallic and herbo-mineral formulation, herbal drug, water, tail, kanji, cow urine etc. are used for their processing to make it free from toxicity along with addition of some properties viz. brittleness, porosity, increase surface area due to the presence of herbal exudate like tannins, alkaloid etc.
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Interface and surface analysis for pharmaceutical applications: challenges and recent advances

Interface and surface analysis for pharmaceutical applications: challenges and recent advances

Characterising spatial and temporal changes of the API composition (stability) and distribution in a formulation during uptake and release is essential to understand drug performance. As the interactions of a tablet or drug delivery particle with its biological surrounding takes place at the solid-liquid interface, characterising surface and interfacial properties of the formulation become extremely important. 11, 12 However, analysing these materials and their surfaces under physiologically relevant conditions presents a significant challenge. Routine dissolution tests only provide limited information about the distribution of APIs within a tablet. 8 Surface analysis techniques such as X-ray photoelectron spectroscopy (XPS) and mass spectrometry have been used but for these ex-situ methods the effect of sample preparation for analysis in low pressure environments is a critical issue. 8 The continued development of surface analysis techniques operating under near ambient conditions 13, 14 has the potential to address this issue.
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A PHARMACOGNOSTICAL AND PHYSICO CHEMICAL ANALYSIS OF ABHAYADI VATI: AN AYURVEDIC POLYHERBAL FORMULATION

A PHARMACOGNOSTICAL AND PHYSICO CHEMICAL ANALYSIS OF ABHAYADI VATI: AN AYURVEDIC POLYHERBAL FORMULATION

In the era of increasing demand for indigenous medicines, maintaining quality standards is the need of the hour. Standardisation of compound formulations is lagging behind because of absence of reference standards. Abhayadi vati is an important Ayurvedic formulation containing Haritaki (Terminalia chebula Retz.), Pippali (Piper longum Linn.), Draksha (Vitis vinifera Linn.), Dhanvyavas (Fegonia cretica Linn.), Sita (Sugar), all the constituents are available and prepared according to the reference present in Yogratnakara Amlapitta nidana chikitsa-35. [1] Hence the present study was undertaken to standardize the compound Ayurvedic formulation through Pharmacognostical and pharmaceutical evaluation. The sample was subjected for various phytochemical parameters like water soluble extractive (48.96%w/w), alcohol soluble extractive (48.03% w/w), ash value (10% w/w), loss on drying (17.82% w/w), the pH (6.5) and hardness (6.5 kg/cm 2 ). The HPTLC, solvent system was Toluene: ethyl acetate (9 :1), showed the presence of 7 spots at 254nm and 2 spots at 366nm. Thus, the physiochemical and microscopic characters achieved may provide guidelines for standardization of formulation Abhayadi vati.
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