Abstract

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

N. V. Suresh Kumar Devaka,*, V Madhusudhan Rao, Yugandhar Parepalli, Murthy Chavali

ABSTRACT

An isocratic, RP-HPLC method was developed for the quantitative determination of Tolpersione Hydrochoride (TOL) and Diclofenac Sodium (DIC) in combined-dosage form. Eclipse XDB C18 column, (150mm X 4.6mm X 5μ, make: Waters) with mobile phase containing water (pH 4.5 adjusted with Potassium dihydrogen Phosphate) and Methanol in the ratio of (60: 40, v/v) was used. The flow rate was 0.8 mL/min, column temperature was 30°C and effluents were monitored at 258 nm. The retention times and correlation co-efficient of TOL and DIC were 3.523 min & 4.766 min and 0.99 & 0.99, respectively. The proposed method was validated for linearity, accuracy, precision, specificity and robustness. Recovery of TOL and DIC in formulations was found to be in the range of 97-103% and 97-103% respectively. Confirms the non-interferences of the excipients within the formulation. Due to its simplicity, rapidness and high precision this method was successfully applied to the estimation of TOL and DIC in combined dosage forms.

Keywords: RP-HPLC, Method Development, Tolperisone Hydrochloride, Diclofenac sodium.