Print ISSN:-2394-2789
Online ISSN:-2394-2797
CODEN : IJPCN9
Original Article
Author Details :
Volume : 10, Issue : 1, Year : 2023
Article Page : 31-38
https://doi.org/10.18231/j.ijpca.2023.006
Abstract
The present study describes a new accurate and precise stability indicating reverse phase HPLC method for quantitative computation of pantoprazole sodium and Aspirin from physical simulated mixture. The proposed chromatographic method employs Hypersil ODS C18 column (250 x 4.6 mm, 5?) as the stationary phase and combination of methyl alcohol and water in ratio of 70: 30 v/v as the elution medium. Overall separation was carried out at 0.8 ml/minute flow rate and elution was monitored at 254 nm. The proposed system gave well resolved peak of Aspirin and Pantoprazole sodium with elution time of 2.32 and 5.85 minute respectively. Same system was effective in separation of active components and degradation products when the components were subjected to forced degradation as per regulatory guidelines (ICHQ1). Finally, the optimized method was successfully validated as per ICH Q2R1 guidelines and applied for quantitative analysis of both active components in synthetic mixture.
Keywords: Validation, ICH, Aspirin, Pantoprazole sodium
How to cite : Yadav P, Patel P, Shukla R, Detholia K, Singh A, Development and validation of stability indicating RP-HPLC method for determination of aspirin and pantoprazole sodium in synthetic mixture stability indicating HPLC method. Int J Pharm Chem Anal 2023;10(1):31-38
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