JOURNAL OF CHILEAN CHEMICAL SOCIETY

Vol 61 No 2 (2016): Journal of the Chilean Chemical Society
Original Research Papers

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

Shailesh T. Donda
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Vishal B. Baviskar
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Sanjay B. Bari
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Prashant K. Deshmukh
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Darshan S. Deore
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Nayandip M. Girase
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Zamir G. Khan
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Previn O. Patil
Department of Quality Assurance, H. R. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur. Dist. Dhule 425 405 (M.S.)
Vol 61, No 2 (2016): Journal of the Chilean Chemical Society
Published August 13, 2016
Keywords
  • Dicyclomine,
  • RP-HPLC,
  • Tramadol hydrochloride
How to Cite
Donda, S. T., Baviskar, V. B., Bari, S. B., Deshmukh, P. K., Deore, D. S., Girase, N. M., Khan, Z. G., & Patil, P. O. (2016). DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TRAMADOL HYDROCHLORIDE AND DICYCLOMINE IN BULK AND PHARMACEUTICAL FORMULATION. Journal of the Chilean Chemical Society, 61(2). Retrieved from https://jcchems.com/index.php/JCCHEMS/article/view/1

Abstract

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 C18 column (4.6 x 250 mm, 5μ 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-1for tramadol hydrochloride and 10-60μg 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.

Figure 1. Chemical structure of Tramadol hydrochloride.

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