Abstract

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

K.E Pravallika*, D.Lalitha, K.Hemavathi, M.Bhavya, P.Ravi,

Abstract

An isocratic, reversed phase-liquid-chromatographic method was developed for the quantitative determination of Tizanidine and Diclofenac sodium combined-tablet dosage form. A Inertsil ODS column (250*4.6mm, 5μm) with mobile phase containing Potassium dihydrogen phosphate buffer[ pH 6.9]:ACN(55:45) v/v) was used. The flow rate was 1.0mL/min, column temperature was 30°C and effluents were monitored at 228nm.The retention times of Tizanidine and Diclofenac sodium were 2.517 min and 4.223 min, respectively. The correlation co-efficient for Tizanidine and Diclofenac sodium was found to be 0.99 and 0.99, respectively .The proposed method was validated with respect to linearity, accuracy, precision, specificity and robustness. Recovery of Tizanidine and Diclofenac sodium formulations was found to be in the range of 97-103% and 97-103% respectively confirms the non-interferences of the excipients in the formulation. Due to its simplicity, rapidness and high precision. The method was successfully applied to the estimation of Tizanidine and Diclofenac sodium in combined dosageform.

Keywords: RP-HPLC, Tizanidine and Diclofenac sodium.