STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF RELATED COMPOUNDS IN THIOCOLCHICOSIDE FOR INJECTION
Jerripothula Ganesh* and Bandi Veerababu*
ABSTRACT
A novel stability-indicating reverse phase liquid chromatographic (NP-LC) method was developed for the Estimation of Related Compounds in Thiocolchicoside for injection the following parameters give optimised results using columm Cosmicill Adore Ph 150 X 3.9 mm, 3μm with mobile phases Mobile phase A (20Mm of octane-1-sulfonic acid sodium salt solution), Mobile phase-B: (100% Acetonitrile), Mobile phase-C(100% Tetrahydrofuran(THF)) with the gradient program with flow rate of 0.8 mL/min, wave length 360 nM, injection volume 10μL, Run time 45 minutes. The linearity equation were found to be for thiocolchicoside, Colchicoside, N-Deacetyl-N-formyl Thiocolchicoside. Colchicine Y= 19828X+415.6, Y=16424X+1324, Y=4626X+319.8, Y=26173+2468 respectively and LOD and LOD 0.17 and 0.51, 0.18 and 0.55 and 0.19 AND 0.58, 0.17 and 0.51 respectively, for related compound the relative retention time and relative response factor were found to be 0.49 & 0.83, 1.05 &0.23, 1.55&1.32 respectively. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.
Keywords: Thiocolchicoside, Development, Reverse phase liquid chromatography, Stability-indicating.
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