Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF PANTOPRAZOLE AND ASPIRIN USING REVERSE PHASE HPLC METHOD IN COMBINED TABLET DOSAGE FORM

*Shahid Afridi, Dr. Brajesh Kumar Arjariya, Mrs. Sheenam Mansuri, Mr. Rahim Khan and Dr. Mohd. Jalaluddin

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Abstract

RP-HPLC method was developed for the determination of Pantoprazole & Aspirin (ASP) in bulk and dosage form. Mobile phase use for the separation of Panto & 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 Panto 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 Panto and 20-100μg/mL of ASP. The % RSD is found to be less than 2%. The resolution between Panto and ASP is 11.55 and the tailing factors of both are less than 2.0. Theoretical plates for Panto and ASP are 5060, and 9367, respectively. Total run time is 15min. The developed RPHPLC method was accurate, precise, selective and rapid for simultaneous estimation of Pantoprazole and Aspirin in the pharmaceutical dosage form.”

Keywords: Pantoprazole, Aspirin, RP-HPLC validation.