ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF HALOBETASOL PROPIONATE AND MUPIROCIN IN THE RATIO 1:40 BY U.V. SPECTROSCOPY AND RP- HPLC METHODAbstract
The present work encompasses the development of two classical UV spectroscopy methods and an RP-HPLC method for the concurrent assessment of Halobetasol propionate and Mupirocin inculcating a statistical approach. The UV spectroscopy methods developed herein include absorption ratio method and first derivative spectroscopy method. The wavelength maxima selected for Absorption ratio method were 240 and 220 nm for Halobetasol Propionate and Mupirocin respectively. The zero crossing points selected were 240.626 nm and 220.180 nm for Halobetasol Propionate and Mupirocin respectively for first derivative spectroscopy. The chromatographic separation was achieved by using CHROMBUDGET C18 (250 × 4.6 mm) 5 µm column, mobile phase consisting of Acetonitrile: phosphate buffer (65:35 v/v, pH 3.2), at 1 ml/min flow rate and detection wavelength was 230 nm The retention time of Halobetasol propionate, and Mupirocin was found to be 8.647 ± 0.06 min and 3.357±0.123 min, respectively. Linearity was observed in the concentration range of 5.125 – 5.75 µg/ml for Halobetasol propionate and 5-30 µg/ml for Mupirocin respectively. The analytical method was validated as per ICH, Q2 (R1) guidelines. The developed method was simple, specific and economic, which can be used for simultaneous estimation of Halobetasol propionate and Mupirocin in the gel dosage form.
A. Bana *, M. A. Sathe and S. J. Rajput
Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery Systems, Pharmacy Department, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara, Gujarat, India.
03 July 2018
05 September 2018
15 September 2018
01 March 2019