Abstract

STABILITY-INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF THIOCOLCHICOSIDE AND ETODOLAC IN TABLET DOSAGE FORM BY RP-HPLC METHOD

Manda Swapna*, Rongali Indu, Soudamini Alekh Charan and P. Uma Devi

ABSTRACT

A simple, sensitive, accurate reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the stability indicating analytical method development for the determination of Etodolac and Thiocolchicoside has been developed and validated. Separation was carried out on agilent HPLC system equipped with XBD plus C18 column (150 × 4.6 mm i.d.) and UV/VIS detector using Acetonitrile: potassium dihydrogen phosphate buffer (70:30, v/v) as the mobile phase, and detection was carried out at 231nm. The linearity was found to be in the range of 10-50 μg/ml and 10-50μg/ml with (r2=0.992, and r2=0.991) for THC and ETD respectively. The sharp peaks obtained were having clear baseline separation with a retention time of 1.733 min for THC and 2.027 min for ETD with resolution 2.05 The forceddegradation studies performed in acidic, basic, oxidative, photolytic and thermal conditions at different time intervals. The method was validated as per the International Council for Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.

Keywords: Etodolac, Thiocolchicoside, HPLC, Stability indicating.