RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DICLOFENAC SODIUM, TRAMADOL HYDROCHLORIDE AND CHLORZOXAZONE FROM THEIR COMBINED TABLET DOSAGE FORM
Keywords:
Diclofenac sodium, Tramadol Hydrochloride, Chlorzoxazone, RP-HPLC method, Analytical method validationAbstract
Objective: The objective of the current study was to develop and validate the RP-HPLC method for the simultaneous estimation of Tramadol Hydrochloride, Chlorzoxazone and Diclofenac sodium from their combined tablet dosage form
Methods: The current method describes RP-HPLC method for the estimation of Tramadol Hydrochloride, Chlorzoxazone and Diclofenac sodium from their combined tablet dosage form. The mobile phase used was Acetonitrile: 0.05M Disodium Hydrogen Phosphate buffer pH 3.5 adjusted with 10% v/v Ortho Phosphoric acid(50:50 v/v) and Hypersil ODS C18 (250 mm x4.6 mm, 5.0 μ particle sizes) was used as a stationary phase with detection wavelength of 220 nm.
Result: Linearity was obtained in the concentration range of 15-75 μg/ml, 100-500 μg/ml and 20-100 μg/ml for TRM,CHL and DIC respectively. The % recovery was found to be 99.41 -99.84%, 99.30 - 99.74 % and 99.6 - 99.97 % for DIC, TRM andCHL respectively. The LOQ was found to be 3.33, 3.95 and 36.71 μg/ml for DIC, TRM andCHL respectively. The proposed method has been validated as perICH Q2R1 guidelines and successfully applied to the estimation of TRM, DIC andCHL from their combined Tablet dosage form.
Conclusion: The method was found to be simple, accurate, precise, and suitable for the estimation of Tramadol Hydrochloride, Chlorzoxazone and Dicofenac sodium from their combined tablet dosage form.
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