Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF OXYCLOZANIDE AND LEVAMISOLE HCl

Mrinalini C. Damle* and Sanchita A. Kale

ABSTRACT

A simple and rapid stability indicating HPLC method for simultaneous estimation of anthelmintic drugs, Oxyclozanide and Levamisole HCl was successfully developed. The stationary phase used was Thermo C18 (250 x 4.6 mm) column with a mobile phase consisting of mixture of Acetonitrile:Methanol:Water in a ratio of 50:30:20 v/v at a flow rate of 1ml/min. Detection was carried at 220nm. The retention time observed was 2.1 ±0.1 min for Oxyclozanide and 5.9 ±0.1 min for Levamisole HCl. The column was maintained at ambient temperature and 20μl of solutions were injected. The eluted compound was detected by using PDA detector. The linear regression analysis data for calibration plot show good relationship with coefficient of regression value, r2=0.99in the concentration range 2-10 μg/ml for oxyclozanide and 5-25 μg/ml for Levamisole HCl. Stress degradation study includes acid and base hydrolysis, oxidation, and thermal and photolytic stress conditions as per ICH Q1A (R2) guidelines. This method can be applied to determination of stability of Oxyclozanide and Levamisole HCl. The suitability of this HPLC method for quantitative determination of Oxyclozanide and Levamisole HCl was proved by validation in accordance with requirements of ICH guidelines Q2A(R1).

Keywords: Oxyclozanide, Levamisole HCl, HPLC, Stability, Validation.