Abstract
The bio-analytical method development of Maralixibat using Elobixibat as an internal standard is a convenient, fast, accurate, and consistent new LC-MS technique and was validated. The present work explains the development of the LC-MS/MS bio-analytical method by RP-18(150x4.6 mm, 3.5µ) column and a binary mixture(0.1% formic acid & methanol) of organic mobile phase in the ratio 60:40. By using liquid-liquid extraction process, these drugs are removed from rat plasma. The linearity in the standard curve was observed under the experimental concentration range. 10%-200% (6-12ng/ml) of Maralixibat. The calibration plots were linear with a regression coefficient of R2> 0.999. Precision, Accuracy, Stability results, and Matrix effect were observed within the acceptable limit. The method is more accessible and effective for analyzing the sample in the body fluids. The work represents that Specificity, Suitability, Accuracy, and linearity parameters ideally agree with the USFDA guidelines and are efficiently practiced in rat plasma for pharmacokinetic studies
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