Abstract

SIMULTANEOUS ESTIMATION AND VALIDATION OF TOLPERISONE AND ETODOLAC IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

S. Kiran Kumar*, E Tejashwi, and Dr. C. Parthiban

ABSTRACT

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Tolperisone and Etodolac in pharmaceutical dosage form. The column used was Kromasil C18 (150mm x 4.6 mm, 5) in isocratic mode, with mobile phase containing phosphate buffer and methanol (65:35 v/v). The buffer is prepared by adding 0.77gm of ammonium acetate in a 1000ml of volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then pH adjusted to 3.7 with orthophosphoric acid solution. The flow rate was 1.0 ml/ min and effluents were monitored at 272 nm. The retention times of Tolperisone and Etodolac were found to be 2.208 min and 4.947 min, respectively. The linearity for Tolperisone and Etodolac were in the range of 37.5-225μg/ml and 100-600μg/ml respectively. The recoveries of Tolperisone and Etodolac were found to be 98.86% to 100.88% w/v and 98.30% to 101.28%w/v, respectively. The proposed method was validated and successfully applied to the estimation of Tolperisone and Etodolac in combined tablet dosage forms.

Keywords: Tolperisone, Etodolac, Buffer, Methanol, Validation and ICH Guidelines.