Method development and validation for determination of thiocolchicoside in drug product using reversed liquid chromatogrpahy.

摘要

Thiocolchicoside (TCC) is the active ingredient of the drug Myoril with the capacity to reduce muscle pain and may act as a muscles relaxant to produce neuromuscular conjugation as in the form of blockade. TCC is a muscle relaxant that shows no sedating side effects. TCC shows to be an effective and safe as monotherapy in the treatment of muscle spasms. In treatments of muscle symptoms such as spasms and pain Thiocolchicoside is often prescribed with other drugs, such as anti-inflammatoryones ones and vitamins. The way the muscle relaxants work is by affecting the central nervous system.;A reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed for both determination of Thiocolchicoside and impurities/degradants in raw material and finished product. Separations were performed on a Water column: 250mm x 4.6 mm, 5?m particle size at 25?C. The mobile phase composed of buffer 25mM Monobasic Potassium Phosphate (solvent A) and 100% Acetonitrile (solvent B). The mobile phase was Acetonitrile and buffer (17:83 V/V) with flow rate 1.0 ml min-1. The pH value of buffer was adjusted to 2.9 with Phosphoric Acid. UV detection was performed at 260 nm. The degradation study was performed under acidic and basic conditions, oxidation conditions, and heat and UV light conditions.