Authors : Ravindrakumar L. Bakal , Jagdish Manwar, Rajesh Jadhao and Dipak Kumbhar
Page Nos : 425-434
Description :
Plackett-Burman design was successfully applied for the development of chromatographic method for the determination of tramadol hydrochloride from bulk drug and tablet formulation. The effect of simultaneously varying the flow rate, temperature and concentration of acetonitrile in mobile phase phosphate buffer (KH2PO4, 0.02M, pH 5.8) on the chromatographic responses was studied with the help of response surface methodology (RSM). From RSM optimum regions were selected to be +1, +1 and +1 for flow rate (1 ml/min), temperature (25°C) and concentration of acetonitrile in mobile phase phosphate buffer (KH2PO4, 0.02M, pH 5.8) (60%, v/v), respectively. Linearity was observed in the range of 1–5 µg/ml with r2 value 0.9998. Obtained LOD and LOQ values were found to be 0.024 and 0.052 µg/ml, respectively. Developed method was validated as per ICH guidelines and was successfully used for the analysis of tablet formulation.
Keywords: Plackett-Burman design, Response surface methodology, Chromatography, Tramadol hydrochloride
