Development and Validation of Chemometric Assisted FTIR Spectroscopic Method for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Pure and Pharmaceutical Dosage Forms

Abstract

Objectives: To develop a new Chemometric assisted Fourier transform infrared (FTIR) spectroscopic method for the simultaneous estimation of valsartan and hydrochlorothiazide in pharmaceutical dosage forms.Methods: The method involves the preparation of solid pellets of valsartan and hydrochlorothiazide using KBr and direct measurement using reduced path length cell. The wave numbers for quantitative estimation were selected with aid of chemometrics software and the spectra were measured in absorbance mode.Results: The infrared spectra showed different peaks with baseline correction, among which intense, clear and proportionate peaks were selected at 1600 cm-1 and 3361 cm-1 corresponding to amide (C=O) and amine (N-H) functional groups for valsartan and hydrochlorothiazide respectively for quantitative estimation were assessed using Chemometrics. Beer Lambert’s law was obeyed over the concentration range of 5-25µg/mg for valsartan and 10-50 µg/mg for hydrochlorothiazide. The method was validated according to ICH guidelines.Conclusion: The developed method was cost effective and fulfilled most validation requirements in a range of concentrations suitable for quality control of both in pure and solid dosage form. This method can be used as an alternative method for HPLC, UV or pharmacopoeial methods as quality control check in pure and marketed formulations.

Keywords: Chemometrics; FTIR; Hydrochlorothiazide; ICH guidelines; Method validation Valsartan