RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC AND TOLPERISONE IN TABLET DOSAGE FORM
Abstract
Objective: To develop a simple and cost effective reverse phase high performance liquid chromatography method for simultaneous estimation of Diclofenac and Tolperisone in tablet dosage form.
Methods: Chromatography was carried out isocratically at 30°C ± 0.5°C on an XDB C-18 column (4.6 x 150mm, 5μ particle size) with a mobile phase composed  of acetonitrile -phosphate  buffer  pH-3  (30:70% v/v)  at  a  flow rate  of 1.0  mL/min. Detection was carried out using a PDA detector at 260 nm. Validation parameters were studied as per ICH guidelines.
Results: The retention times for Diclofenac and Tolperisone are 2.2 min and 4.7 min respectively. The linearity range for Diclofenac and Tolperisone are 12.5-125µg/mL and 37.5-375 µg/mL respectively. The percentage recoveries of Diclofenac and Tolperisone are 99.96% and 100.65% respectively. The correlation coefficients for both components are close to 1.
Conclusion: This method is fast, accurate, precise and sensitive hence it can be employed for routine quality control of tablets containing both drugs in industries.
Â
Keywords: RP-HPLC, Diclofenac, Tolperisone, Simultaneous estimation.
Â
Downloads
References
Dietrich WS, Edmond CK. Pharmacology of diclofenac sodium. The American Journal of Medicine 1986, 80; 4 Suppl 2: 34–38.
Ku EC, Wasvary JM, Cash WD. Diclofenac sodium (GP 45840, Voltaren), a potent inhibitor of prostaglandin synthetase. Biochem. Pharmacol 1985; 24: 641–643.
Menasse R, Hedwall PR, Kraetz J, Pericin C, Riesterer L, Sallmann A, Ziel R, Jaques R. Pharmacological properties of diclofenac sodium and its metabolites. Scand. J. Rheumatol 1978; 22: 5–16.
Brogen RN, Heel RC, Pakes GE, Speight TM, Avery GS. Diclofenac sodium: a review of its pharmacological properties and therapeutic use in rheumatic diseases and pain of varying origin.1980; Drugs 20: 24–48.
Kocsis, P., Tarnawa, I., Kovacs, G., and Szombathelyi, Z., Mydeton: a centrally acting muscle relaxant drug from Gedeon Richter LTD. Acta Pharm Hung 2002; 72: 49–61.
Vora A.Tolperisone. J Assoc Physicians India 2010; 58:127-8.
Emami J, Ghassami N, Talari R. A rapid and sensitive modified HPLC method for determination of diclofenac in human plasma and its application in pharmacokinetic studies. DARU 2007; 15 suppl 3: 132-138.
Avgerinos A, Karidas T, Malamataris S. Extraction less high-performance liquid chromatographic methodfor the determination of diclofenac in human plasma and urine. J Chromatogr 1993; 619 suppl 2: 324-329.
El-Sayed YM, Abdel-Hameed ME, Suleiman MS, Najib NM. A rapid and sensitive highperformance liquid chromatographic method for the determination of diclofenac sodium in serum and its use in pharmacokinetic studies. J Pharm Pharmacol 1988; 40 suppl 10: 727-729.
Moncrieff J. Extractionless determination of diclofenac sodium in serum using reversed-phase highperformance liquid chromatography with fluorimetric detection. J. Chromatogr 1992; 577 suppl 1: 185-189.
Hiari T, Matsumuto S, Kishi I. Simultaneous analysis of several non-steroidal anti-inflammatory drugs in human urine by high-performance liquid chromatography with normal solid-phase extraction. J. chromatogr. B Biomed Sci Appl 1997; 692: 375-88.
Blaghrough IS, Daykin MM, Doherty M, Patrick M, Shaw PN. High performance liquid chromatographic determination of naproxen, Ibuprofen and diclofenac in plasma and synovial fluid in man. J Chromatogr 1992; 578: 251-257.
Giagoudakis G, Markantonis SL. An alternative high-performance liquid chromatographic method for the determination of diclofenac and flurbiprofen in plasma. J Pharm Biomed Anal 1998; 17 suppl 4-5: 897-901.
Liawruangrath, S., and Liawruangrath, B., High performance thin layer chromatographic determination of tolperisone hydrochloride. J Pharm Biomed Anal 1999; 20: 401–404.
Liawruangrath, S., Liawruangrath, B., and Pibool, P. Simultaneous determination of tolperisone and lidocaine by high performance liquid chromatography. J Pharm Biomed Anal 2001; 26: 865–872.
Miskolczi P, Vereczkey L, Frenkl R, Gas-liquid chromatographic method for the determination of tolperisone in human plasma: pharmacokinetic and comparative bio-availability studies. J Pharm Biomed Anal 1987; 5: 695–700.
Liawruangrath S, Liawruangrath B, Pibool P. Simultaneous determination of tolperisone and lidocaine by high
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.