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ISSN 2063-5346
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STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR TRILACICLIB IN PHARMACEUTICAL SUBSTANCE AND ITS VALIDATION

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J. Sumalatha, D. Vasavi devi , R. Reddy Lakshmi Devi
» doi: 10.31838/ecb/2023.12.si6.384

Abstract

A simple, precise, accurate, sensitive, and specific RP-HPLC method for the determination of Trilaciclib in the pharmaceutical dosage form. Chromatogram was run through Inertsil C18 150 x 4.6 mm, 5μ. Mobile phase containing 0.01N KH2PO4: Acetonitrile taken in the ratio 60:40 was pumped through the column at a flow rate of 1.0ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 220.0 nm. The retention time of Trilaciclib was found to be 2.347 min. %RSD of the Trilaciclib was found to be 1.3%. %RSD of Method precision of Trilaciclib was found to be 0.7. %. Recovery was obtained as 99.29% for Trilaciclib. The LOD and LOQ values obtained from the regression equation of Trilaciclib were 0.29, and 0.89. The Regression equation of Trilaciclib is y = 100035x + 16845. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.

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