RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC AND TOLPERISONE IN TABLET DOSAGE FORM

  • venkata raveendra babu vemula pacific university
  • Pankaj Kumar Sharma

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.

 

Keywords: RP-HPLC, Diclofenac, Tolperisone, Simultaneous estimation.

 

Author Biography

venkata raveendra babu vemula, pacific university
pharamaceutical analysis and quality assurance

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vemula, venkata raveendra babu, and P. K. Sharma. “RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC AND TOLPERISONE IN TABLET DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 6, no. 7, Aug. 2013, pp. 186-9, https://innovareacademics.in/journals/index.php/ajpcr/article/view/307.
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