Development and validation of a high resolved and novel Stability indicating HPLC Method for the simultaneous Quantification of Halometasone and Its Impurities in Pharmaceutical Formulation

The aim of the present study is to develop a simple, precise and novel HPLC method for the separation and quantification of Halometasone and its known impurities 1, 2 and 3 in formulations. separation was achieved on ProntoSIL ODS C18 (250×4.6 mm; 5 µ id) as stationary phase, 10mM ammonium acetate buffer at pH 5.7: methanol in the ratio of 35:65 (v/v) as mobile phase at a flow rate of 1.0 mL/min and UV detector wavelength of 218 nm. In the optimized condition, well resolved and retained peaks were observed at retention time of 6.6min, 4.9 min, 8.7 min and 10.3 min for Halometasone, impurity 1, 2 and 3 respectively. The calibration curve was found to be linear with in the concertation range of 50-350 µg/mL for Halometasone and 0.5 -3.5 µg/mL for its three impurities with very high correlation. The precision, accuracy, ruggedness and robustness were performed in the developed method and all the parameters were found to be with in the acceptable limit for Halometasone and its impurities. Forced degradation study performed in acidic, base, peroxide, thermal and UV light condition and the method can effectively separate the unknown compounds formed in the stress exposer along with known impurities and standard Halometasone. The method can effectively separate and quantify the known impurities and Halometasone in formulation. Hence the method can be used for the routine analysis of Halometasone and its impurities in formulation and stress degradation. Key works: Halometasone; pharmaceutical impurities; HPLC method; stress degradation.