Development and Validation of Stability Indicating RPHPLC Method for Simultaneous Estimation of Beclomethasone Dipropionate and Clotrimazole

Abstract

The aim of the present study was to develop a validated stability indicating reverse phase
high performance liquid chromatography (RP-HPLC) method for simultaneous estimation
of Beclomethasone dipropionate (BEC) and Clotrimazole (CL) in bulk and combined dosage
form ( CLOCIP-B cream). An isocratic, RP-HPLC method was developed using Hi Q Sil C18
(250 x 4.6 mm, 5 μm) column using 1 mM ammonium acetate buffer and acetonitritle (10:90
v/v) as mobile phase at flow rate of 1 ml/min at detection wavelength of 223 nm.
The chromatographic conditions yield good separation between drugs with retention time
(RT) of 4.227 ± 0.013 min and 6.440 ± 0.027 min, for BEC and CL, respectively. The method
was validated with respect to linearity, precision, accuracy and robustness. The data of linear
regression analysis indicated a good linear relationship over the range of 10-60 μg/ml for
BEC and 5-30 μg/ml for CL concentrations with a correlation coefficient (r 2
) of 0.996 for
BEC and 0.995 for CL. The drugs were subjected to forced degradation under different
conditions. The developed method was found to be simple, sensitive, selective, accurate,
and repeatable for simultaneous analysis of BEC and CL and can be adopted for routine
analysis of these drugs in bulk and pharmaceutical dosage form.