G. Saravanan, Md. Yunoos, Ch. Swapna Latha
G. Saravanan*, Md. Yunoos, Ch. Swapna Latha
Department of Pharmaceutical Chemistry, Bapatla College of Pharmacy, Bapatla-522101, Andhra Pradesh, India
Volume - 7,
Issue - 2,
Year - 2014
A simple, rapid, selective, sensitive, linear, precise and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Tapentadol and Paracetamol in pharmaceutical dosage form. Separation was achieved on a reverse phase Hypersil BDS C18 (100 x 4.6 mm, 5 µ particle size) column at ambient temperature using a mobile phase consisting of Methanol: Acetonitrite: Water (50:10:40 v/v/v), at a flow rate of 1.0 ml/min. The UV detection wavelength was 273 nm and 10 µl of sample was injected. The linearity was found to be 10-60 µg/ml for Tapentadol and 65-390 µg/ml for Paracetamol with a correlation coefficient of 0.9992 and 0.9997 respectively. Retention times were found to be 2.96 min and 4.95 min for Tapentadol and Paracetamol respectively. The mean % recoveries were found to be 99.74 + 0.32 % for Tapentadol and 99.88 + 0.17 % for Paracetamol. The method was validated as per the ICH guidelines for sensitivity, linearity, accuracy and precision. The % RSD for precision, robustness and ruggedness of the proposed method was found to be less than 2 %. Hence the developed method can be successfully employed for routine quality control analysis of Tapentadol and Paracetamol in pharmaceutical dosage forms.
Cite this article:
G. Saravanan, Md. Yunoos, Ch. Swapna Latha. Development and validation of RP-HPLC method for simultaneous estimation of Tapentadol and Paracetamol in bulk and combined dosage form. Asian J. Research Chem. 7(2): February 2014; Page 220-224.