Simultaneous Determination of Verapamil Hydrochloride and Gliclazide in Synthetic Binary Mixture and Combined Tablet Preparation by Chemometric-Assisted Spectroscopy

Rahul Bhaskar,Mahendra K Sagar,Radhika Bhaskar,Krishnamoorthy Bhat,Vipin Saini

doi:10.4236/jasmi.2012.23026

Rahul Bhaskar, Mahendra K Sagar + Show 3 more

Open Access

https://doi.org/10.4236/jasmi.2012.23026

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Abstract

In this study, the simultaneous determination of verapamil hydrochloride and gliclazide in pharmaceuticals by chemometric approaches using UV spectrophotometry has been reported. Verapamil hydrochloride (VER) (Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl) ethyl] methylamino]propyl]-3, 4-dimethoxy-α-(1-methylethyl) hydrochloride) is an L-type calcium channel blocker of the phenylalkylamine class. It has been used in the treatment of hypertension, angina pectoris, and cardiac arrhythmia. Gliclazide (GLZ) (1-(Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(4-methylphenyl) sulphonyl]urea) is an oral hypoglycaemic (anti-diabetic) drug and is classified as a second generation sulfonylurea. Spectra of VER and GLZ were recorded at several concentrations within their linear ranges between wavelengths of 200 nm to 400 nm in 0.1N HCl. Partial least squares regression (PLS) and principle components regression (PCR) were used for chemometric analysis of data and the parameters of the chemometric procedures were optimized. The recoveries were satisfactory and statistically comparable. The method was successfully applied to pharmaceutical formulation, tablet, with no interference from excipients as indicated by the recovery study results. The proposed methods are simple, rapid and can be easily used in the quality control of drugs as alternative analysis tools.

Highlights

One of the basic problems in the dissolution testing of pharmaceutical preparations, containing two or more drugs is the simultaneous quantitative analysis without any chemical separation step
Diluted samples from each stock were utilized for max determination of individual component followed by serial dilution of stocks with 0.1N HCl to obtain the aliquots falling in linearity calibration range
The cross validation and validation statistical parameters obtained after applying Partial least squares regression (PLS) and principle components regression (PCR) to the spectrophotometric data are shown in Table 3, showing reasonably low absolute and relative root-mean square errors (RMSECV and REP%, respectively)

Summary

Introduction

One of the basic problems in the dissolution testing of pharmaceutical preparations, containing two or more drugs is the simultaneous quantitative analysis without any chemical separation step. Earlier when chemometricing was not in frequent use, HPLC was one of the methods of choice of researchers for the analysis of the drugs showing an overlapped spectrum on u.v. spectrophotometry. HPLC being an expensive and time consuming method, from the last few years, chemometric spectrophotometry is immensely attracting the analysts and playing an important role in the accurate detection of complex drug mixtures. Several spectroscopic methods have been developed for the estimation of VER and GLZ individually and with other active pharmaceutical ingredients [4,5,6,7,8,9]. To the best of our knowledge, no simultaneous estimation of these two compounds has been reported in combination using u.v. spectrophotometer

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