DEVELOPMENT OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD AND ITS VALIDATION FOR ESTIMATION OF FORMOTEROL FUMARATE ROTA CAPSAbstract
A simple, rapid and reproducible HPLC method was developed and validated for the estimation of Formoterol Fumarate Rotacaps. Symmetry C8 (4.6×150mm, 5 µ) column, in isocratic mode with mobile phase containing Ammonium Acetate Buffer pH 5.0 and Acetonitrile (80:20) was used. The flow rate was 1.0 ml/min and the analyte was monitored at 254 nm. The retention time for Formoterol was about 4.6 mins. The system was validated for precision, accuracy, linearity, limit of detection and limit of quantitation. The Linearity was obtained in the concentration range of 30µg/ml to 180µg/ml with correlation coefficient of 0.999. The percentage recovery of Formoterol was found to be in the range of 98% -102%. Therefore it was concluded that the proposed method can be used for routine analysis of Formotero Fumarate Rota caps.
Siraj Ahmed*, B. Jayakar and M. A. Aleem
MESCO College of Pharmacy, Mustaidpura, Karwan Road, Hyderabad, Andhra Pradesh, India
24 September, 2010
26 November, 2010
12, January 2011