ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF TOLPERISONE AND DICLOFENAC SODIUM BY RP-HPLCOLPERISONE AND DICLOFENAC SODIUM BY RP-HPLC
Journal Title: Int J of Pharm Res & Analy - Year 2015, Vol 5, Issue 1
Abstract
A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Tolpersione and Diclofenac sodium in bulk and pharmaceutical formulations. Separation of Tolpersione and Diclofenac sodium was successfully achieved on an Eclipse XDB C18 (150mm X 4.6mm X 5μ Make: Waters) or equivalent in an isocratic mode utilizing KH2PO4 buffer ( pH 4.5): Methanol (60:40%v/v) at a flow rate of 0.8 mL/min and eluate was monitored at 258nm, with a retention time of 3.523 and 4.766 minutes for Diclofenac sodium and Tolpersione. The method was validated and the response was found to be linear in the drug concentration range of 50μg/Ml to150 μg/mL for Diclofenac sodium and 50μg/mLto150 μg/mL for Tolpersione. The value of the correlation coefficient was found to be 0.999 and 0.999 for Diclofenac sodium and Tolpersione. The LOD and LOQ for Tolpersione were found to be 0.334 , 1.113 respectively. The LOD and LOQ for Diclofenac sodium were found to be 0.1301, 0.4338 respectively. This method was found to be good percentage recovery for Diclofenac sodium and Tolpersione were found to be 98.00 and 100.00 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for linearity, range, accuracy, precision, specificity and robustness.
Authors and Affiliations
Shivaji D*, , Usha Sree G , Ajitha A , Uma Maheswara Rao V
Keywords
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- EP ID EP106593
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