DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TRAMADOL HYDROCHLORIDE AND DICYCLOMINE IN BULK AND PHARMACEUTICAL FORMULATION

SHAILESH T DONDA, VISHAL B BAVISKAR, SANJAY B BARI, PRASHANT K DESHMUKH, DARSHAN S DEORE, NAYANDIP M GIRASE, ZAMIR G KHAN, PRAVIN O PATIL
2016 Journal of the Chilean Chemical Society (Print)  
The present study was designed to develop and validate a simple, sensitive, precise and accurate RP-HPLC method for simultaneous estimation of dicyclomine and ethylmorphine in bulk and tablet dosage form. The chromatographic separation was achieved on Discovery C 18 column (250 × 4.6 mm, 5 µm) as stationary phase with a mobile phase of water (pH 5.4 adjusted with orthophosphoric acid): acetonitrile (40:60 v/v) at a flow rate of 1 ml/min and PDA detection at 215 nm. The proposed method was
more » ... ed method was validated for system suitability, specificity, linearity, accuracy, precision, LOD, LOQ, and robustness as per ICH guidelines. The retention times of dicyclomine and ethylmorphine were found to be 3.166 ± 0.02 and 4.204 ± 0.19 min respectively. The calibration curves were linear in the concentration range of 50% to 150% of the working concentration (r 2 =0.999) for both the drugs in a binary mixture. The accuracy was found to be 98.61 % and 99.24 % for dicyclomine and ethylmorphine respectively. The LOD was found to be 0.05 µg/ml, and 0.20 µg/ml and LOQ were found to be 0.17 µg/ml and 0.62 µg/ml for dicyclomine and ethylmorphine respectively. The percentage recoveries for both drugs were in the range of 98-101%. Hence the proposed RP-HPLC method can be used in routine analysis of tablets containing dicyclomine and ethylmorphine.
doi:10.4067/s0717-97072016000200001 fatcat:xlivzpy42vc3xbormgfen2b54u