M. Alekhya et al., J. Sci. Res. Phar. 2014, 3(1), 49-53
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Simultaneous Estimation of Cetrizine Hydrochloride and Montelukast Sodium by U.V
M.Alekhya1, 2* S.Likhitha1, A.Jyothirmayee2, Mohd Sohail2, M.Ramakoteswarrao2 *1Guru Nanak Institutions technical campus (GNITC), School of pharmacy, Hyderabad, INDIA.
2Nalla Narshima Reddy Education Society’s and Group of Institutions, Hyderabad, INDIA.
Received on: 14-03-2014; Revised and Accepted on: 27-03-2014
ABSTRACT
T
his present work is concerned with the application of simple, accurate, precise and highly selective u.v method for simultaneous estimation of cetrizine HCl and Montelukast Sodium in Bulk drugs. The developed method was validated for linearity, accuracy, precision, limit of detection, limit of quantification, robustness parameters and found to be in good accordance with the prescribed values. Thus the proposed method can be successfully applied for simultaneous determination of Cetrizine HCl and Montelukast Sodium in routine bulk drug analysis.Keywords: Cetrizine HCl, Montelukast Sodium, U.V, Validation, Bulk drugs.
INTRODUCTION
C
etirizine hydrochloride is a second generation anti histamine which is used in the treatment of allergy in respiratory tract and cold symptoms. Chemically it is - [2- [4- [(4-chlorophenyl) phenylmethyl] -1-piperazinyl] ethoxy] acetic acid, dihydrochloride (Fig. 1). It is a white crystalline powder which is odourless and freely soluble in water. It is a major metabolite of hydroxyzine and a racemic selective histamine receptor (H1) [1] antagonist. Numerous authors have reported CTZdetection methods in biological fluids and pharmaceutical formulations [2-6]. It used in the treatment of urticaria, angioedema,
allergies, and hay fever [7].
Fig. 1:Structure of Cetirizine
Fig. 2: Structure of Montelukast Sodium
Montelukast sodium is a antiasthmatic used in the treatment of asthma effectively8. Chemically it is [R-(E
)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[.2-(1-hydroxy-1- methylethyl) phenyl] propyl] thiomethyl] cyclopropane acetic acid monosodium salt (Fig. 2). It is approved by the us food and drug administration for the use by the children [9] from 2-12 years of age
in the dosage of 5mg/day .it is a white to off-white powder which is odourless and freely soluble in ethanol, methanol and water. Montelukast sodium may be given due consideration for the use of first line therapy in patients with mild persistent asthma [10, 11].
Recently different UV methods have been reported for the
*Corresponding author:
M. Alekhya
Department of Pharmaceutical Analysis,
Nalla Narshima Reddy Education Society’s and Group of Institutions, Hyderabad, India.
*E-Mail: [email protected]
estimation of Montelukast sodium both individually and also in combination with other drugs in pharmaceutical dosage forms, which are either tedious or expensive methods [12-17].
The aim of this work is to develop accurate, specific, cost effective, repeatable and validated u.v method for the simultaneous estimation of Cetirizine hydrochloride and Montelukast sodium in the bulk drug samples.
EXPERIMENTAL
I
nitially method development work was started by takingUV-visible spectra from 400-200 nm of Cetirizine hydrochloride (10ppm) and Montelukast sodium (10ppm) standard solutions. By observing the overlain spectra of standard solutions λmax 234 nm was taken for to develop method.
Preparation of standard solution:
10mg of Cetirizine hydrochloride and 10mg of Montelukast sodium was dissolved into 10ml of diluent (Acetonitrile is taken into a volumetric flask and sonicated for 5 min to degas it).
From the above solution pipette out 0.25ml of Cetirizine hydrochloride and 0.50ml Montelukast sodium and make up the volume up to the mark in 10ml volumetric flask.
Preparation of sample solution:
0.25ml of cetirizine hydrochloride taken from stock solution and maked up to the mark with mobile phase.0.50ml of Montelukast sodium is taken from stock solution and maked up to the mark with mobile phase. Both are taken in combine form.
Fig. 3: UV Estimation of Cetirizine HCl and Montelukast Sodium
M. Alekhya et al., J. Sci. Res. Phar. 2014, 3(1), 49-53
Accuracy: The accuracy for the assay of cetirizine Hcl and Montelukast sodium is determined by Preparing solutions of drug substance cetirizine hydrochloride 12.5ppm, 25ppm and 37.5ppm and Montelukast sodium at levels from 25ppm,50ppm and 75ppm of target concentration as per the test solution and Samples of the standard solution, accuracy -50%,100% 150% solutions were analysed.
Precision: The precision of the analytical method was studied by analysis of multiple sampling of homogeneous sample.
Linearity: The linearity of detector response is established by plotting a graph of absorbance versus concentration (on X-axis concentration and on Y-axis Absorbance) and the correlation coefficient is determined. A series of solutions of 0.5ppm to 5ppm concentration of cetirizine hydrochloride and 1ppm to 10ppm concentration of Montelukast sodium are taken and observed under u.v Fig. 4 & 5.
Fig. 4: Linearity Curve of Cetrizine Hcl Fig. 5: Linearity Curve of Montelukast Sodium
Limit of Detection: Solutions of drug substance cetirizine hydrochloride (0.1ppm) and Montelukast sodium (0.2ppm) of target concentration were taken and tested.
Limit of Quantification:A Series of solutions were prepared using cetirizine hydrochloride (0.1ppm) and Montelukast sodium (0.2ppm) working standard at concentration levels and Measured the peak area response of the solution.
RESULTS AND DISCUSSION
T
he u.v estimation of Cetrizine Hcl and Montelukast sodium were carried out by using mobile phase having a mixture of 35ml of Buffer, 65ml of Acetonitrile. The mobile phase was sonicated for 10min to remove gases.The acceptance criteria for accuracy is that the mean % recovery of Cetirizine hydrochloride and Montelukast sodium at
each level should be not less than 98.0 and not more than 102.0 and the results are shown in Table 1.
The acceptance criteria for the system precision is that the % Relative standard deviation of Peak area of cetirizine hydrochloride and Montelukast sodium from the five replicate samples should be not more than 2.0% and the results are shown in
Table 2.
The acceptance criteria for the method precision is that the % relative standard deviation of %Assay from five test preparations of cetirizine hydrochloride and Montelukast sodium should be not more than 2.0%.
The acceptance criteria for the linearity is that the Correlation Coefficient should be not less than 0.999 and for the limit of detection is that the S/N ratio value shall be 3 for LOD solution and for the limit of quantification is that the S/N ratio value shall be 10 for LOQ solution and are listed in Table 3.
Table No. 1: Summary of results of Accuracy parameter for Cetirizine HCl and Montelukast Sodium
% of Conc.
Cetirizine HCl Montelukast Sodium
% Recovery % RSD % Recovery % RSD
80 % 98.63 0.394 98.27 0.272
100 % 99.07 0.592 99.43 0.477
120 % 100.20 0.831 100.61 0.829
Denotes average of three estimations
Table No. 2: Summary of results of Precision parameter for Cetirizine HCl and Montelukast Sodium
Precision Cetirizine HCl Montelukast Sodium
Inter-day (%RSD) 0.873 1.034
Intra-day (%RSD) 0.928 0.784
Denotes average of six estimations
Table No. 3: Summary of results of Linearity parameter for Cetirizine HCl and Montelukast Sodium
Cetirizine Hcl Conc. (ppm) a Avg. Abs Montelukast Sodium Conc. (ppm) Avg. Abs
0.5 0.021 1 0.028
1 0.043 2 0.049
3 0.131 6 0.142
4 0.164 8 0.193
M. Alekhya et al., J. Sci. Res. Phar. 2014, 3(1), 49-53
Scan spectrum curves of different concentrations are given below :
Fig. 6: Cetirizine HCl-1 ppm Fig. 7: Cetirizine HCl-3 ppm
Fig. 8: Cetirizine HCl-3 ppm Fig. 9: Cetirizine HCl-4 ppm
Fig. 10: Cetirizine HCl-5 ppm
M. Alekhya et al., J. Sci. Res. Phar. 2014, 3(1), 49-53
Fig. 14: Montelukast Sodium-6ppm Fig. 15: Montelukast Sodium-8ppm
Fig. 16: Montelukast Sodium-10ppm
Table No. 4: Summary of results of LOD and LOQ parameter for Cetirizine HCl and Montelukast Sodium
Cetirizine HCl Montelukast Sodium
LOD a ± SD 0.15 0.2
LOQ a ± SD 0.5 0.65
Regression coefficient (r2) 0.9981 0.9993
CONCLUSION
T
he developed UV method was developed and validatedfor the simultaneous determination of cetirizine HCl and Montelukast sodium in bulk drugs. The validation data indicate good precision, accuracy and reliability of the method, the developed method offers several advantages in terms of simplicity in mobile phase, easy sample preparation steps and comparative short run time which make the method specific and reliable for its intended use in simultaneous determination of Montelukast and cetirizine in bulk drugs.
The assay result obtained by this method is in fair agreement. This method can be use for the determination of cetirizine HCl and Montelukast sodium in commercial formulations.
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Conflict of interest: The authors have declared that no conflict of interest exists.
