Abstract

The multivariate calibration method, partial least square regression (PLS) was applied for the simultaneous spectrophotometry determination of amitriptyline hydrochloride (AMT) and chlordiazepoxide (CHL) in their mixtures. The parameters of chemometric technique were optimized and the proposed method was validated with synthetic samples and applied to analyze these drugs in pharmaceutical products with good accuracy and precision. The results were compared with those given by United State Pharmacopoeia method. The square of the correlation coefficients (R2) for predicted AMT and CHL with the proposed method in a test sample were 0.9951 and 0.9897 respectively. The relative standard deviation for commercial tablets in the proposed method and USP standard method were 0.42 and 2.61%, respectively.

Highlights

  • Amitriptyline hydrochloride 10,11-dihydro-N,N-dimethyl-5H-dibenzo [a,d] cycloheptane-∆5γpropylamine hydrochloride (AMT) is used commonly in combination with chlordiazepoxide 7chloro-2-(methyl-amino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide (CHL)

  • The aim of this paper is to investigate the ability of partial least square regression (PLS) and PCR methods for quantifying binary mixtures of amitriptyline hydrochloride and chlordiazepoxide without prior separation and to apply the optimized method in pharmaceutical preparations

  • The two drugs studied show a strong overlap in their absorption spectra and univariate analysis method can not be applied for resolving this mixture

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Summary

Introduction

Amitriptyline hydrochloride 10,11-dihydro-N,N-dimethyl-5H-dibenzo [a,d] cycloheptane-∆5γpropylamine hydrochloride (AMT) is used commonly in combination with chlordiazepoxide 7chloro-2-(methyl-amino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide (CHL). The mixture of these two drugs is used for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The determination of these drugs is a frequent analytical problem in quality control of the pharmaceutical industries. The two drugs studied in this work show a strong overlap between their absorption spectra.

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