Development and validation of rp- hplc method for the simultaneous estimation of tramadol hydrochloride and dicyclomine in bulk and pharmaceutical formulation

• SHAILESH T DONDA ^[1] ; VISHAL B BAVISKAR ^[1] ; SANJAY B BARI ^[1] ; PRASHANT K DESHMUKH ^[1] ; DARSHAN S DEORE ^[1] ; NAYANDIP M GIRASE ^[1] ; ZAMIR G KHAN ^[1] ; PRAVIN O PATIL ^[1]
  1. [1] H. R. Patel Institute of Pharmaceutical Education and Research Department of Quality Assurance
• Localización: Journal of the Chilean Chemical Society (Boletín de la Sociedad Chilena de Química), ISSN-e 0717-6309, ISSN 0366-1644, Vol. 61, Nº. 2, 2016, págs. 2852-2855
• Idioma: inglés
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• Resumen

  • A simple, specific, accurate and precise reversed phase high pressure liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of tramadol hydrochloride (TRA) and dicyclomine (DCY) in bulk and tablet dosage form. Chromatography was carried on Phenomex Gemini C column (4.6 x 250 mm, 5u particle size) using mixture of methanol, acetonitrile and 0.1% triethylamine (TEA) pH 3.0 (adjusted with orthophophoric acid) in the ratio of 35:5:60 (v/v/v) respectively as a mobile phase. The flow rate 1.0mL min-1 and detection wavelength 275 nm was selected for the present study. The retention time of tramadol hydrochloride and dicyclomine were 4.13 min and 9.06 min respectively. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 50-300 μg mL-1 for tramadol hydrochloride and 10-60 μg mL-1 for dicyclomine. The proposed method was validated with respect to linearity, precision, accuracy, specificity and robustness. The proposed method was found to be simple, rapid, accurate, precise and reproducible. Thus it can be applied for routine quality control analysis of tramadol hydrochloride and dicyclomine in tablet dosage form.