Abstract

METHOD DEVELOPMENT AND VALIDATION OF ASPIRIN AND OMEPRAZOLE BY USING USING RP-HPLC METHOD

*Mahendra D. and Sravani Purnima P.

ABSTRACT

A new method was established for simultaneous estimation of Aspirin and Omeprazole by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Aspirin and Omeprazole by using Agilent C18 column (4.6×150mm)5μ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: phosphate buffer(KH2PO4 and K2HPO4) phosphate pH 3 (pH was adjusted with Orthophosphoric acid), detection wavelength was 240 nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.427 mins and 4.432 mins. The % purity of Aspirin and Omeprazole was found to be 99.87% and 100.27% respectively. The system suitability parameters for Aspirin and Omeprazole such as theoretical plates and tailing factor were found to be 2733, 1.6 and 3500 and 1.4, the resolution was found to be 4.6. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Aspirin and Omeprazole was found in concentration range of 25μg-125μg and 15μg-75μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.1% and 103.1%, %RSD for repeatability was 0.9 and 0.21, % RSD for intermediate precision was 2.0 and 0.16 respectively. The precision study was precision, robustness and repeatabilty. LOD value was 3.17 and 0.1372 and LOQ value was 5.60 and 0.132 respectively.

Keywords: Method Development, Aspirin, Omeprazole, RP-HPLC method, Validation.