Abstract

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPLC METHOD FOR ESTIMATION OF RISEDRONATE SODIUM

Mrinalini C. Damle* and Lahu B. Birajdar

ABSTRACT

A simple stability indicating HPLC method for the estimation of Risedronate sodium has been developed and validated. Elution was carried out using a mobile phase consisting of phosphate buffer (pH-4.65): acetonitrile in ratio 85:15 v/v which was sonicated to degas and delivered at a flow rate of 1 ml/min at ambient temperature. The retention time of Risedronate sodium was 2.24 ± 0.2 minutes. Studies were performed using an HPLC system equipped with a PDA detector; the response was monitored at 265 nm. The drug was subjected to stress testing as per ICH Q1A (R2) and ICH Q1 (B). The method was validated according to ICH Q2 (R1) guidelines. The data of linear regression analysis indicated a good linear relationship over the range of 10-60 μg/ml concentrations with correlation coefficient value of 0.995. The accuracy of the method is indicated by good recovery in the range of 98-102% with less than 2% RSD. The limit of detection and limit of quantification were found to be 0.64 and 1.95 μg/ml respectively. The proposed method can be applied for monitoring the stability and to the routine quality control analysis of Risedronate sodium.

Keywords: Risedronate sodium, Stability studies, Forced degradation, HPLC, Validation.