A Simultaneous Estimation of Clotrimazole and Its Impurities

Pharmaceutical Science-Pharmaceutical analysis for Novel drug formulation

Abstract

A simple, efficient and reproducible method for the simultaneous determination of Clotrimazole and its Impurities (Imidazole and (2-chlorophenyl) phenyl methanone (2-chlorobenzophenone)) has been developed  using  reversed  phase  high performance  liquid  chromatography.  The  separation  was carried out using a mobile phase consisting of Potassium dihydrogen phosphate buffer (pH 7.2): Acetonitrile (25:75 %v/v). Column  used was SHIMADZU C18   (4.6x250 mm, 5 µm) with  a flow rate of  0.8  ml/min  and the column temperature was maintained at 40 °C. The detection wavelength used was at 220 nm. The retention time of Clotrimazole,  Imidazole and 2-chlorophenyl phenyl methanone (2-chlorobenzophenone)was   8.12, 7.56 and 3.02 min respectively. Linearity of Clotrimazole and its Impurity are in range of 0.013-0.076 mg/mL. For System Suitability  %  RSD  was  found  to  be  1.60  for  Clotrimazole,  1.29  for  Imp-D,  1.15  for  Imp-E..The  Mean% Recoveries  were  found  to  be  within  the  range  of  98-102  %.Analytical  parameters  were  calculated  and  a statistical evaluation was included.