DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF TAZAROTENE AND HALOBETASOL PROPIONATE IN FIXED-DOSE COMBINATION

Abstract

Simple, precise and accurate UV-Spectrophotometric simultaneous equation method for estimation of Halobetasol propionate (HALO) and Tazarotene (TAZA) were developed and validated as per ICH guidelines. This Method involves solving of simultaneous equations based on measurement of absorbance at two wavelengths 238 nm and 351 nm (λmax of HALO and TAZA) in methanol. HALO obey the Beer’s law in the concentration ranges 5-25μg/ml and TAZA (1- 5μg/ml). % Recovery for both the drugs were in the range of 98.46±0.854% to 99.21±0.688 for halo and 97.10±0.781 to 99.04±0.770 for TAZA respectively indicating excellent accuracy. The methods were precise, with a relative standard deviation of less than 2% for both drugs. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus, method can be used for routine monitoring of drugs in industry for the assay of bulk drugs and commercial formulation.