stability indicating and method validation

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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

An additional peak was observed for acid degradation at retention time 2.9 minutes indicating degradation of 7.6% for simultaneous analysis of PYR and SLP (Fig. 4). Additionally, basic degradation studies also revealed the presence of an extra peak at 2.9 minutes (Fig. 5). This specifies formation of degradation products with a degradation of 7.46% for simultaneous study of PYR and SLP. In case of oxidative and photolytic studies, no additional peaks were observed as well as there is no variation in drug peak area, representing degradation was not found for the drugs under oxidative (Fig. 6) and photolytic conditions (Fig. 7).
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A validated stability-indicating HPLC method for determination of varenicline in its bulk and tablets

A validated stability-indicating HPLC method for determination of varenicline in its bulk and tablets

Furthermore, the climate is widely varying worldwide, and consequently, the quality of pharmaceutical product of VRC is greatly affected by the change in the environ- mental factors. As well, VRC-containing tablets are imported from outside of many countries, consequently there is a major concern about its quality after exposure to transportation, storage, and other conditions. There- fore, quality control for VRC-containing tablets is criti- cally concerned in these countries. In literature, only one report has been found describing the separation and quantitation of process-related substances to VRC tarta- rate [13], however there was no report on the stability- indicating assay for VRC. For these reasons, a stability- indicating method for determination of VRC in its bulk drug and pharmaceutical tablets is essential, particularly, such methods have become an important aspect of any analytical method validation and a part of ICH guidance for pharmaceutical industry [12].
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Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil

Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil

establish its inherent stability characteristics, leading to separation of degradation products and hence supporting the stability of the proposed analytical procedures. It also required that analytical test procedures for stability sam- ples should be stability indicating and they should be fully validated (7 - 10). Hence, an attempt has been made to de- velop and accurate, rapid, specific and reproducible method for the determination of Olmesartan and all seven impuri- ties in bulk drug samples along with method validation as per ICH norms. The stability tests were also performed on both drug substances and drug product as per ICH norms.
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Development and validation of a stability indicating rp hplc method for simultaneous determination of haloperidol and benzhexol in pharmaceutical combined dosage forms

Development and validation of a stability indicating rp hplc method for simultaneous determination of haloperidol and benzhexol in pharmaceutical combined dosage forms

A new, simple, rapid and precise stability indicating reversed- phase high performance liquid chromatographic method was developed for the simultaneous estimation of Haloperidol and Benzhexol in bulk and combined pharmaceutical dosage forms. The method is simple, accurate, linear, sensitive and reproducible as well as economical for the effective quantitative analysis of Haloperidol and Benzhexol in bulk and combined dosage forms. The method was validated, and all the method validation parameters were tested and shown to produce satisfactory results. The method is free from interactions of the other ingredients and excipients used in the formulations. Finally, concluded that the method is suitable for use in the routine quality control of Haloperidol and Benzhexol in active pharmaceutical ingredients and in pharmaceutical dosage forms.
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Development and validation of stability indicating HPTLC method for determination of Prasugrel

Development and validation of stability indicating HPTLC method for determination of Prasugrel

A sensitive, selective, precise and stability indicating (in accordance with ICH guidelines) High- Performance Thin Layer Chromatographic method of analysis for Prasugrel was developed, to resolve drug response from that of their degradation products. The method employed TLC aluminium plates precoated with silica gel 60 F 254 as the stationary phase. The solvent system

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Development and validation of stability indicating HPTLC method for
determination of fluindione

Development and validation of stability indicating HPTLC method for determination of fluindione

To check accuracy of the method, recovery studies were carried out by adding standard drug to sample at three different levels 80, 100 and 120 %. Basic concentration of sample was 1000 ng/band from SB. The drug concentrations were calculated from respective linearity equation. The results of the recovery studies indicated that the method is accurate for estimation of drug in tablet dosage form. The results obtained are shown in Table 2.

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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF TROXIPIDE

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF TROXIPIDE

To check the repeatability, the response of sample solution was recorded six times. The intraday and inter day precision was performed as per the procedure given in previous section. For both repeatability and intermediate precision, the %RSD value was found to be always less than 2; which reveal that the method is precise (Table 2).

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 DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPLC METHOD FOR DETERMINATION OF BOCEPREVIR

 DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPLC METHOD FOR DETERMINATION OF BOCEPREVIR

The developed method is stability indicating, since the drug peak was found to be pure as confirmed by peak purity profiling study. This proves that there is no interference of degradation product in analytical peak. The degradation product obtained under hydrolytic conditions are well resolved. The method is specific, accurate, precise, and robust and can be used for routine quality control as well as assessing the stability of Boceprevir.

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Development and validation of stability indicating RP-HPLC method for voriconazole

Development and validation of stability indicating RP-HPLC method for voriconazole

Thus the study shows that voriconazole undergoes degradation in acidic, alkaline and neutral hydrolytic conditions whereas it is relatively stable when exposed to dry heat, oxidation and photolytic conditions. A stability-indicating method was developed, which resolved all the degradation products formed under variety of conditions. The degradation products formed under acid, alkali and neutral hydrolysis condition are same which is conÞ rmed from UV spectrum of the degraded product. The method proved to be simple, accurate, precise, speciÞ c and selective. Hence it may be used to assay of the product during stability studies.
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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF FELODIPINE IN TABLET DOSAGE FORM

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR DETERMINATION OF FELODIPINE IN TABLET DOSAGE FORM

HPTLC method and Chromatographic condition In the proposed HPTLC method, the samples were streaked on the pre-coated TLC plates in the form of a narrow band 6 mm in length, 10 mm from the bottom and margin and 10 mm a part at a constant flow rate of 150nl/s by using a nitrogen aspirator. A Camag Twin Trough Chamber was saturated for 20 min at room temperature (25 ± 2°C) with the mobile phase containing a mixture of n-hexane: ethyl acetate in the ratio of 6:4 (v/v). After chamber saturation, the plates were developed to a distance of 80 mm and then dried in hot air. Densitometric analysis was carried out using a Camag TLC Scanner 3 (Camag) in the absorbance mode at 366 nm for all measurements. The slit dimension was kept at 5.0 mm × 0.45 mm and a scanning speed of 20 mm/s was employed. FEP was detected at Rf of 0.53 ± 0.027. The chromatograms were integrated using win CATS evaluation software (Version 1.1.3.0).
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Development and Validation of Stability Indicating HPLC Method for Estimation of Dapsone

Development and Validation of Stability Indicating HPLC Method for Estimation of Dapsone

Accepted: 12 Apr 2018 Objective: reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of The aim of the present study was to develop a validated stability indicating Dapsone. Experimental approach: An isocratic, RP-HPLC method was developed using neosphere C 18 (150 x 4.6 mm, 3.5 μm) column using 10 mM ammonium acetate buffer (pH 3) and methanol (60:40 v/v) as mobile phase at flow rate of 1 ml/min at detection wavelength of 295 nm. Findings and discussion: The retention time (RT) of drug was 4.3 ± 0.328 min. The method was validated with respect to linearity, precision, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 2-12 μg/ml concentrations with a correlation coefficient (R 2 ) of 0.997. Dapsone was subjected to different stress testing conditions.
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Development and Validation of a Stability Indicating HPLC Assay Method for Determination of Warfarin Sodium in Tablet Formulation

Development and Validation of a Stability Indicating HPLC Assay Method for Determination of Warfarin Sodium in Tablet Formulation

The objective of the current study was to developed simple, precise and accurate isocratic reversed-phase stability indicating high performance liquid chromatography [HPLC] assay method validated the for determination of warfarin in solid pharmaceutical dosage forms. Isocratic reversed phase high performance liquid chromatography [RP-HPLC] separation was achieved on a SGE SS wakosil (150 mm × 4.6 mm i.d., C8RS 5 µm particle size) column using mobile phase of acetonitrile and 50 mM sodium hydrogen phosphate dibasic dihydrate buffer pH 3.0 (50:50 v/v) at a flow rate of 1.0 mL min -1 , the injection volume was 20.0 μL and the
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DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF PAROXETINE HYDROCHLORIDE AND CLONAZEPAM IN PHARMACEUTICAL DOSAGE FORMS

DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF PAROXETINE HYDROCHLORIDE AND CLONAZEPAM IN PHARMACEUTICAL DOSAGE FORMS

found to be accurate and precise with good and consistent recoveries at all levels studied. The good % recovery in tablet forms suggests that the excipients present in the dosage forms have no interference in the determination. The %RSD was also less than 2% showing high degree of precision of the proposed method. In addition, simple isocratic elution and easy extraction procedure offered rapid and cost-effective analysis of Paroxetine and Clonazepam. The proposed method can be used for routine analysis of Paroxetine and Clonazepam in combined dosage form. It can be also used in the quality control in bulk manufacturing.
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STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF OLMESARTAN, CHLORTHALIDONE AND CILNIDIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF OLMESARTAN, CHLORTHALIDONE AND CILNIDIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

The system suitability tests were conducted before performing the validation and the parameters were within the acceptance criteria like retention times were 3.357 min, 2.838 min and 3.722min for Olmesartan, chlorthalidone And Cilnidipine, plate count was >2000, peak tailing was <2 and the %RSD of peak areas of six injections were ≤ 2% (Table 1). Hence the proposed method was successfully applied to routine analysis without any problems.

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Development and Validation of Stability Indicating HPLC Method for the Determination of Process and Degradation Related Impurities in Telmisartan Drug Substance

Development and Validation of Stability Indicating HPLC Method for the Determination of Process and Degradation Related Impurities in Telmisartan Drug Substance

S1). The present method employed C8 column with mobile phase-A consists of 0.05% trifluoroacetic acid and mobile phase-B as acetonitrile. This method also having LCMS compatibility for impurity profiling. The forced degradation studies [15-18] were carried out to prove the method is stability indicating and was thoroughly validated according to ICH guidelines [19]. The method was found to be specific, sensitive, precise, reproducible, which can be used as quality control tool.

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Development and validation of a stability indicating RP-HPLC method for Balofloxacin

Development and validation of a stability indicating RP-HPLC method for Balofloxacin

For testing linearity seven calibration standards were prepared in the range of 5 to 100 µg/mL (5, 10, 20, 40, 60, 80 and 100 µg/mL). Standard curve was obtained by plotting peak area against concentration and the evaluation of linearity was done by linear regression analysis using least square method.

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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ALBENDAZOLE

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ALBENDAZOLE

Linearity was found for ABZ by using standard stock solution 100 µg /ml. To establish linearity, the stock solution was applied on the plate using 100 µl syringe with the help of Linomat V applicator, to give spots of concentrations 200-700 ng/spot for Albendazole. Application volume 0.2, 0.3, 0.4, 0.5, 0.6, 0.7 was applied on plate using Linomat 5 to obtain concentrations 200, 300, 400, 500, 600,700ng/spot. Plate was developed according to proposed method. After the development, plate was scanned at 244 nm and results obtained are shown in Table No.1 and calibration plot obtained was shown in Fig. No.3
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STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF AZELNIDIPINE

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF AZELNIDIPINE

By comparing two method, it can be concluded that spectroscopic method was found to be simple and rapid First order spectroscopic method was found to be more accurate as compared to zero order spectroscopic method. The value of % RSD for intra-day and inter- day precision was found to be less than 2. The value of % Recovery greater than 98% for this method shows that the method is accurate and free from the in interference of excipients used in formulation. % Recovery of formulation were found to be 99-102%. It was concluded that developed method is simple, accurate, precise and reliable rather than already developed RP- HPLC method. The developed RP- HPLC method was subjected to stability indicating studies for Azelnidipine. It was found that the interfering peak from degraded products or solvent did not interfere with estimation of drug and the developed method was found to be specific for estimation of Azelnidipine.
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DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC ASSAY METHOD FOR DETERMINATION OF LAMOTRIGINE IN TABLET FORMULATION

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC ASSAY METHOD FOR DETERMINATION OF LAMOTRIGINE IN TABLET FORMULATION

1 ml of TEA and adjust the pH 6 with OPA, 40:60, v/v) flowing through the column at a constant flow rate of 1.0 ml/ min. The mobile phase was filtered through nylon 0.22 µm membrane filters and was degassed before use (30 min). A Thermo (C-18) Column (5 µm, 250mm x 4.60mm) was used as the stationary phase. By considering the chromatographic parameter, sensitivity and selectivity of method for drugs, 225 nm was selected as the detection wavelength for UV-Visible detector.

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Stability indicating analytical method development and validation for the simultaneous estimation of paracetamol and etodolac using Rp HPLC method in both bulk and pharmaceutical dosage form

Stability indicating analytical method development and validation for the simultaneous estimation of paracetamol and etodolac using Rp HPLC method in both bulk and pharmaceutical dosage form

Accuracy was determined by means of recovery experiments, by the determination of % mean recovery of sample at three different levels (50-150%). At each level, three determinations were performed. Percent mean recovery was calculated as shown in Table 5 & 6. The accepted limits of recovery are 90%-110% for the process of determining recovery of the standard from the formulation at three different levels of 50%, 100% and 150%. All observed data are within the required range which indicates good recovery values and hence the accuracy of the method developed.
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