RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ASPIRIN AND OMEPRAZOLE IN BULK AND DOSAGE FORM

Abstract

RP-HPLC method was developed for the determination of Omeprazole (OME) & Aspirin (ASP) in bulk and dosage form. Mobile phase use for the separation of OME & ASP is methanol and 0.05%OPA in water (pH= 3.5) with ratio of 60:40. The Colum used as C18 (Cosmosil) 4.6×150mm and flow rate 0.7mL/min. UV detector is used and the detection wavelength is 231nm. Retention time of OME and ASP are 4.61 & 8.03 min, respectively. This method was validated as per ICH guidelines. Linearity was observed at 10-50µg/mL of OME and 20-100µg/mL of ASP. The % RSD is found to be less than 2%.The resolution between OME and ASP is 11.55 and the tailing factors of both are less than 2.0.Therotical plates for OME and ASP are 5060, and 9367, respectively. Total run time is 15min. The developed RP-HPLC method was accurate, precise, selective and rapid for simultaneous estimation of Omeprazole and Aspirin in the pharmaceutical dosage form.” Keyword: Omeprazole, Aspirin, RP-HPLC validation.