.

ISSN 2063-5346
For urgent queries please contact : +918130348310

Method Development And Validation Of Azelnidipine And Telmisartan In Humanplasma Using RP-HPLC

Main Article Content

Padmavathi Sakinala1*, Shruthi Mareedu2, Kameswara Rao Sankula3, Shaik Abdul Rahaman4, Ramu Bhadramraju5, M.Showreelu6
» doi: 10.48047/ecb/2023.12.si5a.0480

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation ofAzelnidipine and Telmisartan in human plasma was developed and validated. By usingCentrifugation, the sample preparation was prepared. Chromatogram was run through StdInertsil C18 (150 x 4.8 mm, 5m) Mobile phase containing BufferDiSodiumHydrogenPhosphate: Acetonitrile taken in the ratio 65:35 was pumped throughcolumn at a flow rate of 1.0ml/min. Buffer used in this method wasDiSodiumHydrogenPhosphate buffer. For the separation of Azelnidipine and Telmisartan, Internal Standard [IS] used is Saxagliptin. The Temperature was maintained at 30°C.Optimized wavelength selected was 228nm. Retention time of Azelnidipine and Telmisartanand Internal Standard were found to be 2.139 min and 2.422 min and 3.025 The standardcurve was linear (R2 >0.995) over the concentration range of 6.0-240 ng/ml of telmisartan &0.45-18 ng/ml. All the analytical validation parameters were determined as per ICHguidelines The bioanalytical method developed approach was selective, robust, and reliable,as accuracy, precision, recovery, and other validation parameters were all within therecommendations' limitations. The peaks produced for the drug of interest and the internalstandard was well separated from one another without any plasma interferences, and thepeaks weresymmetrical with an adequate tailing factor. The method has the potential to bevery beneficial in therapeutic drug monitoring (TDM),bioequivalence research,pharmacokinetics studies, toxicology, and biomedical investigations

Article Details