Stability indicating RP-HPLC method development and validation for estimation of Crisaborole in topical dosage form

Abstract

A simple, specific, accurate, precise , rapid, robust and selective stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for assay and related substances and validated for quantification of Crisaborole with its excipients in its topical dosage form. Forced degradation study is done to determine stability of the product. In mobile phase Water: Methanol (30: 70 v/v), the maximum of Crisaborole was measured to be 241nm. The technique is highly sensitive, with linearity ranging from 5 to 25g/ml (regression equation: y = 316606x - 427583; r2 = 0.9992). For verifying and testing this approach, several parameters according to ICH recommendations and USP are used. The detection and quantitation limits were determined to be 0.1094 and 0.3316 g ml-1, respectively. The results revealed that the process is accurate, specific, and repeatable (RSD 2%), as well as easy, inexpensive, and less time consuming, and suitable for determining Crisaborole in topical dosage form. The method have been robust under various variation with flow rate, detection wavelength and column oven temperature. The drug was exposed to stress conditions. Method resolves all degraded product as compared to Crisaborole. Developed method can be used routinely for estimation of drug Crisaborole with its excipient methyl paraben in dosage form and stability sample.