Abstract

DEVELOPMENT AND VALIDATION OF A SIMPLE RP-HPLC METHOD FOR THE ESTIMATION OF ATORVASTATIN IN SELF EMULSIFYING DRUG DELIVERY SYSTEM (SEDDS)

SM Ashraful Islam*, Irin Dewan, Rahima Khatun, Sayed Shabbir Haider and Md. Selim Reza

ABSTRACT

A simple, selective and rapid reversed phase High Performance Liquid Chromatographic (RP-HPLC) method for the analysis of atorvastatin in self emulsifying drug delivery system (SEDDS) has been developed and validated. The chromatographic system consisted of a LC-20 AT pump, SPD-20 A UV/visible detector. The separation was achieved from C18 column at 300C with a mobile phase consisting of 0.025 M phosphoric acid solution: acetonitrile (60:40 v/v, pH 3.0 adjusted with 80% phosphoric acid) at a flow rate of 1.2 ml/min and the retention time was 2.737± 0.019 min. The method was found selective and able to resolve drug peaks from formulation excipients. The calibration curve was linear over the concentration range of 2-20 μg/ml (r2 = 0.999). The proposed method was accurate with 100.14 ± 0.57% recovery and precise (%RSD of Intraday variation were 0.55% and 0.58% for Inter day variation). The method has been used to determine potency of prepared SEDDS. Potency in all the cases was found within 99.02%- 100.02%. Therefore, this method can be used as a more convenient and efficient option for the analysis of atorvastatin in self emulsifying drug delivery system (SEDDS).

Keywords: Atorvastatin, Method Validation, HPLC Method, Quantitative Analysis.