A NEW VALIDATED ANALYTICAL METHOD FOR THE ESTIMATION OF AMOROLFINE HYDROCHLORIDE USING UV SPECTROSCOPY IN BULK DRUG AND FORMULATION

Amorolfine (or amorolfin), is a morpholine antifungal drug that inhibits -sterol reductase and cholestenol Δ-isomerase, which depletes ergosterol and causes ignosterol to accumulate in the fungal cytoplasmic cell membranes.This paper describes a simple, accurate, specific and validated method for the estimation of amorolfine hydrochloride in ointment form. A study was carried out of all the parameters established as per ICH guidelines to validate an analytical method for estimation. The method showed high sensitivity with reproducibility in results. The wavelength maxima (λmax) was found to be 219 nm. The linearity for this method was found to be in the range of 05 – 30 μg/ml. The calibration curve (Fig -2) was drawn by plotting graph between absorbance and concentration. This method showed a correlation coefficient of 0.9997. The regression equation of the curve was Y= 0.0227x+0.02641. Method was successfully validated. In addition, this proposed method was simple, sensitive, Easy to apply and requires relatively inexpensive instruments. The proposed method can be used for routine analysis of amorolfine Hydrochloride in bulk as well as in the commercial formulations.