DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC DETERMINATION OF CARVEDILOL PHOSPHATE IN BULK AND PHARMACEUTICAL DOSAGE FORM USING FLUORESCENCE DETECTORAbstract
An accurate, sensitive and precise RP-HPLC –Fluorescence method has been developed and validated for the estimation of Carvedilol Phosphate (CP) from bulk drug and Pharmaceutical Dosage form. The separation was achieved by a Brownlee analytical C18 column (250mm X 4.6mm, 5μm) in isocratic mode, with mobile phase comprises of Acetonitrile : Methanol : Buffer in proportion of 70:20:10v/v/v, buffer was 5mM Potassium Di-hydrogen Phosphate (pH 3.5 adjusted with Ortho Phosphoric Acid). The flow rate of mobile phase was 1.0ml/min and employing fluorescence detection with 280nm excitation and 340nm emission wavelengths. The retention time of Carvedilol Phosphate was 2.20 min.The calibration curve was found to be linear within the concentration range of 10ng/ml to 60ng/ml. The regression data for calibration curve shows good linear relationship with r2 = 0.990. The method was validated in accordance with the requirements of ICH guidelines. Moreover, the proposed analytical method was applied to monitor the formulation commercially available.
Bhavna A. Patel, Sharddha J. Parmar , Jigar B. Patel , Gautam R. Chauhan and Aanandi D. Captain
Assistant Professor, P.G. Department of Pharmaceutical Science, Sardar Patel University, Gujarat, India
21 July, 2012
17 August, 2012
26 October, 2012