Method development and validation for the simultaneous determination of fexofenadine hydrochloride and montelukast sodium using rp-hplc

A new analytical method has been developed for the simultaneous estimation of Montelukast sodium and Fexofenadine hydrochloride in pharmaceutical dosage forms using chemometrically assisted Fourier Transform Infrared (FTIR) Spectroscopy. This method involves preparation of solid pellets of Montelukast sodium and Fexofenadine hydrochloride using Potassium bromide (KBr) with the aid of geometric mixing. The spectra were measured by direct measurement technique using reduced path length in absorbance mode and the equipment was configured to collect spectra at 8cm-1 resolution. The spectra were collected between the ranges of 4000cm-1 to 450cm-1. Infrared spectra of the two drugs showed different functional group peaks with base line correction; from which intense, clear and proportionate peaks at 1704cm-1 and 3421cm-1 corresponding to C=O stretching and O- H group were selected for Montelukast and Fexofenadine respectively for quantitative estimation using chemometrics. Beer-Lambert’s law was obeyed over the concentration range of 5-25 μg/mg for Montelukast and Fexofenadine. The developed method was validated according to International Conference on Harmonisation (ICH) guidelines. The validation parameters - precision, accuracy, limit of quantitation, limit of detection were determined and found to be within the limits. This method was successfully applied for analysis of marketed formulations of Montelukast sodium and Fexofenadine hydrochloride.

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RP-HPLC Method for the Simultaneous Estimation of Ambroxol Hydrochloride and Fexofenadine Hydrochloride in bulk and in a Tablet Mixture

Buchupalli¹,

Srinivas²

2015

J App Pharm Sci

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A simple, rapid and precise reverse phase liquid chromatographic (RP-HPLC) method was developed and subsequently validated for simultaneous estimation of Ambroxol hydrochloride and Fexofenadine hydrochloride in bulk drug and in a synthetic mixture. The method is based on High Performance Liquid Chromatography (HPLC) on a reversed -phase column, Hypersil ODS C18 (Hypersil ODS 250 x 4.6 mm, 5, Make: Thermo Scientific) prepacked column. The separation was carried out using a mobile phase containing a buffer and acetonitrile (56:44 v/v), was pumped at a flow rate of 0.8 mL/min, column temperature at 35º C using UVdetection at 225 nm. Both the drugs were well resolved on the stationary phase and the retention times were around 2.424 minute for Ambroxol hydrochloride and 3.753 minute for Fexofenadine hydrochloride. The method was validated and shown to be linear for both the drugs. The correlation coefficients for Ambroxol hydrochloride and Fexofenadine hydrochloride are 0.9994 and 0.9992 respectively.

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Method development and validation for the simultaneous determination of fexofenadine hydrochloride and montelukast sodium using rp-hplc

Cited by 3 publications

References 28 publications

A Review of Different Analytical Techniques for Fexofenadine Hydrochloride and Montelukast Sodium in Different Matrices

A Review of Different Analytical Techniques for Fexofenadine Hydrochloride and Montelukast Sodium in Different Matrices

Development and Validation of Chemometric Assisted Fourier Transform Infrared Spectroscopic Method for Simultaneous Determination of Montelukast Sodium and Fexofenadine Hydrochloride in Pharmaceutical Dosage Forms

RP-HPLC Method for the Simultaneous Estimation of Ambroxol Hydrochloride and Fexofenadine Hydrochloride in bulk and in a Tablet Mixture

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