Abstract

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR QUANTIFICATION OF OBETICHOLIC ACID IN BULK AND PHARMACEUTICAL DOSAGE FORM

Nagamallika Gorantla* and Srinivas Nandala

Abstract

An appropriate, well-thought-out approach was developed for the assessment of obeticholic acid using the RP-HPLC method. The conditions for the chromatographic analysis were as follows: the column was a Kromasil C18 (150mm*4.6mm5m) with an adaptable sorting of 0.01N Kh2po4: Acetonitrile in a ratio of 70:30, the flow rate was maintained at 1.0 ml/min, the irrefutable proof resolution was 260.0 nm, the temperature of the mixture was maintained at 30oC, and the diluent was of effective direction. As an extra way, conditions were set up. The standard dissimilar times and outcomes were well beneath the affirmation rules, which concentrated the system's sensitivity limitations. R2 was 0.999, and linearity was considered between 25% and 15%. Repeatability was assessed as 1.0 and focal point of the street exactness as 0.9 in terms of precision. Separately, the limits of detection (LOD) are 0.05 g/ml and 0.17 g/ml. Using an out-of-process review of the front line, a decision-making rate of 100.07% was achieved. In all cases, the flawlessness edge was greater than the ethical point and inside the agreeable reach, and debasement assessments of Obeticholic uncomfortable were bundled up. A full-scale strategy was not implemented; nonetheless, this technique can be used for the evaluation of Obeticholic harm plans in the future.

Keywords: HPLC Obeticholic acid, Method development. ICH Guidelines.