Analytical Quality by Design-Based Development and Validation of a Stability Indicating RP-HPLC Method for Quantitative Estimation of Thiocolchicoside in Pharmaceutical Dosage Forms

Abstract

A semisynthetic derivative of the naturally occurring glycoside colchicoside, thiocolchicoside (TCC) functions as a selective competitive GABA-A receptor antagonist. It is frequently used as a skeletal muscle relaxant to treat painful and spastic musculoskeletal disorders. For the quantitative measurement of thiocolchicoside in bulk medication and pharmaceutical tablet dosage forms, a straightforward, quick, accurate, precise, and reliable reversed-phase high-performance liquid chromatographic (RP-HPLC) approach has been developed and validated. A mobile phase consisting of Acetonitrile: 10 mM Ammonium Acetate Buffer (pH 4.5) at a ratio of 40:60 v/v, supplied at a flow rate of 1.0 mL/min, was used to accomplish the chromatographic separation on a Kromasil C18 column (250 × 4.6 mm, 5 µm). At 246 nm, the eluent was tracked. It was discovered that the thiocolchicoside retention period was 5.8 ± 0.05 minutes. For criteria including linearity, precision, accuracy, specificity, robustness, LOD, and LOQ, the method was validated in accordance with ICH Q2(R1). With a correlation value (R²) of 0.9998, the technique demonstrated linearity in the concentration range of 2–20 µg/mL; LOD and LOQ were determined to be 0.24 µg/mL and 0.74 µg/mL, respectively. The recovery rate was between 99.12% and 100.34%. Both the intra-day and inter-day precision %RSD was less than 1%. Thiocolchicoside in commercial tablet formulations was effectively estimated using the verified approach.