RP-HPLC analytical method development and validation of obeticholic acid in bulk and marketed formulation
Keywords:
acetonitrile, obeticholic acid, RP-HPLC, validationAbstract
The purpose of this study is to develop a new analytical RP-HPLC method for quantifying Obeticholic Acid in bulk and commercial formulations. Liquid chromatography is performed on a C18 column and the mobile phase is prepared using 0.1% orthophosphoric acid and acetonitrile in a ratio of 65:35. The flow rate was 1.0 ml / min and the injection volume was 10 ml. The maximum absorption of the drug was 210 nm. The retention time was found to be 2.80 minutes. This method was found to be accurate and linear with a correlation coefficient of 0.999 in the range 2.4-14 mg / mL. The percentage RSD for accuracy was less than 1.8%, averaging 100.05%. All validation parameters were statistically validated according to ICH guidelines and were within acceptable criteria. This method turned out to be simpler, more accurate, more specific, more accurate and more robust. This HPLC method is used for the analysis of obeticholic acid.
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