Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE QUANTIFICATION OF THIOCOLCHICOSIDE IN THIOCOLCHICOSIDE INJECTION

D. Devi Preethi Beula, M. Sankar and K. Dhanalakshmi*

ABSTRACT

A simple, efficient and reproducible RP-HPLC method has been developed for determination of Thiocolchicoside injection dosage form by Eclipse plus C18 (100× 4.6mm; 3.5μm) column using the mobile phase consists of buffer and methanol in the ratio 70:30. The mobile phase was flowed at the rate of 1.5 ml/min and effluent was detected at 258 nm. The retention time of Thiocolchicoside is 6.147 min. The method was validated according to ICH guidelines and the acceptance criteria for system suitability, specificity, linearity, accuracy, precision and ruggedness were met in all cases. The method was linear in the range of 50-150μg/ml of Thiocolchicoside (r2=0.99997). The percentage relative standard deviation for precision was found to be less than 2.0% and the recoveries from tablets were between 80 and 102%. Stability indicating method also performed by various forced degradation conditions. The evaluation of chromatographic peak response of the analyte from every degradation method showed homogeneous and free of co-eluting peaks. Therefore, the proposed method can be successfully used for the routine analysis of Thiocolchicoside in pharmaceutical dosage form without interference

Keywords: Thiocolchicoside, stability indicating, method development, RP-HPLC, validation.