STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF EPROSARTAN MESYLATE AND HYDROCHLOROTHIAZIDE IN BULK AND TABLET DOSAGE FORM

摘要

Objective: The objective of the method was to develop a simple, rapid, efficient, cost effective and reproducible stability indicating reverse phase high performance liquid chromatography method (RP-HPLC) for the simultaneous estimation of eprosartan mesylate and hydroc hlorothiazide in active pharmaceutical ingredient and tablet dosage form Methods: The RP-HPLC analysis was carried out on an enable C18G column with a mobile phase of methanol-acetonitrile-potassium dihydrogen orthophosphate (0.01 M; pH adjusted to 3 with orthophosphoric acid) in the ratio of 20:28:52 (v/v/v). UV detection was performed at 240 nm. Results: The method was found to be linear over a concentration range of 10-600 μg/ml and 0.4-25 μg/ml for eprosartan mesylate and hydrochlorothiazide respectively. The limit of detection was found to be as 3.1 μg/ml and 100 ng/ml for eprosartan mesylate and hydrochlorothiazide respectively. The limit of quantitation was found to be as 10 μg/ml and 100 ng/ml for eprosartan mesylate and hydrochlorothiazide. Recovery was found to be in the range 99-100% and precision less than 1%. Developed method was successfully applied for routine analysis of drug pharmaceutical formulation. Forced degradation studies were performed for eprosartan mesylate and hydrochlorothiazide. The drugs were degraded in acidic, basic and oxidative conditions. The peaks of degraded products were well resolved from the actual drug. Conclusion: The developed method was simple, rapid, accurate, precise and stability indicating for the simultaneous estimation of eprosartan mesylate and hydrochlorothiazide in active pharmaceutical ingredient and tablet dosage form