Журнал хроматографии и методов разделения
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Stability Indicating LC Method for the Estimation of Benazepril HCl and Hydrochlorthiazide in Pharmaceutical Dosage Form

Chhalotiya UK, Varsha LP, Dimal AS, Kashyap KB and Sunil LB

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.