Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF SAROGLITAZAR IN BULK AND PHARMACEUTICAL DOSAGE FORM BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

G. Muneer*, K. Mohitha, G. L. Madhusudhan Reddy, Anjaneya Reddy, D. Mahesh and B. Thangabalan

ABSTRACT

A simple, Précised, Accurate method was developed for the estimation of Saroglitazar by RP-HPLC technique. Chromatographic conditions used were stationary phase BDS100mm x 4.6 mm, 5., Mobile phase water: Acetonitrile in the ratio of 45:55 and flow rate was maintained at 1ml/min. The detection wave length was 214nm and column temperature was set to 30oC and the diluent was used as mobile phase Conditions were finalized for optimized method. The System suitability parameters were studied by injecting the standard five times and results were well under the acceptance criteria. Linearity study was carried out between 10 to60 µg/ml levels, R2 value was found to be as 0.999. The Precision was found to be 1.13 for repeatability and 0.18 for intermediate precision. LOD and LOQ are 0.11µg/ml and0.33µg/ml respectively. By using above method

Keywords: HPLC, Saroglitazar, Method development, ICH Guidelines.