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Abstract

STABILITY INDICATING CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF METOPROLOL SUCCINATE AND BENIDIPINE HCL IN ITS DOSAGE FORM

Saurabh K. Shukla*, Shweta D. Mevada, Dr. Hirak V. Joshi and Dr. J. K. Patel

ABSTRACT

A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Metoprolol Succinate and Benidipine HCl in their combined dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Metoprolol succinate and Benidipine HCl in Their Combined Dosage Form has been developed. The separation was achieved by C18 (25cm x 0.46 cm) Hypersil BDS column and Buffer (Potassium Phosphate, pH 4.0) : Methanol (65:35 %V/V) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 248 nm. Retention time of Metoprolol succinate and Benidipine HCl were found to be 3.427 min and 5.967min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Metoprolol succinate 25-75 μg/ml and for Benidipine HCl 4-12 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Metoprolol succinate and Benidipine HCl in their combine dosage form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in Thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form.

Keywords: Metoprolol succinate, Benidipine HCl, Stability indicating RP-HPLC Method, Validation.


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