Stability Indicating LC Method for the Estimation of Benazepril HCl and Hydrochlorthiazide in Pharmaceutical Dosage Form

Kashyap Kb Sunil Lb

doi:10.4172/2157-7064.1000216

Abstract

A rapid, specific and sensitive reverse phase high performance liquid chromatographic method has been developed and validated for analysis of benazepril hydrochloride and hydrochlorothiazide in both bulk and pharmaceutical dosage form. A sunfire C-18, 250×4.6 mm i.d. and 5 μm particle size column with mobile phase containing water: methanol (55:45, v/v, pH 7). The flow rate was 1.0 mL min-1 and effluents were monitored at 233 nm. The retention time of benazepril hydrochloride and Hydrochlorthiazide was 9.19 min and 3.10 min respectively. Benazepril hydrochloride and hydrochlorthiazide was subjected to acid and alkali hydrolysis, chemical oxidation, wet hydrolysis, dry heat degradation and sun light degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of benazepril hydrochloride and hydrochlorthiazide in tablet dosage forms.

Highlights

Benazepril hyrochloride (BEN) is chemically 3-[[1-(ethoxycarbonyl)3-phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benza zepine-1-acetic acid monohydrochloride (Figure 1A)
The drug solutions containing BEN (10 μg/ml), HCT (10 μg/ml) and their mixture were chromatographed at a flow rate of 1 ml/min with the following mobile phases
The method was successfully used for the determination of drug in their pharmaceutical formulation

Summary

Introduction

Benazepril hyrochloride (BEN) is chemically 3-[[1-(ethoxycarbonyl)3-phenyl-(1S)-propyl] amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benza zepine-1-acetic acid monohydrochloride (Figure 1A). The empirical formula of BEN is C24H28N2O5HCl with a molecular weight 460.96 g/ mole. Hydrochlorthiazide (HCT) is chemically 6-chloro-3, 4-dihydro2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide (Figure 1B). The empirical formula is C7H8ClN3O4S2 with a molecular weight 297.73 g/ mole.

Methods

Findings

Discussion

Conclusion