Abstract

METHOD DEVELOPMENT AND VALIDATION SIMULTANEOUS ESTIMATION OF STABILITY SYSTEM OF LORNOXICAM AND THIOCOLCHICOSIDE BY RP-HPLC

Uppari Amarnath*

Abstract

A new stability-indicating reversed-phase high-performance liqud chromatographic (RP-HPLC) method for the analysis of lornoxicam and thiocolchicoside was developed and validated. The column used was Inertsil –ODS C18 (250 × 4.6 mm,5μ) with flow rate of1.0ml/min using PDA detection at 239nm. The chromatograms were developed using aluminum plates pre-coated with silica gel as a stationary phase and Acetonitrile: water ( 55:45v/v ) as a mobile phase. The described method was linear over a concentration range of 20ppm to 80ppm for the assay of lornoxicam and thiocolchicoside respectively. The retention times of lornoxicam and thiocolchicoside were found to be 2.869min and 3.942min respectively. Results of analysis were validated statistically and by recovery studies. The limit of quantification (LOQ) for lornoxicam and thiocolchicoside were found to be 1.69mg/ml and 1.74mg/ml respectively. Then the limit of detection (LOD) for lornoxicam and thiocolchicoside were found to be 0.56 mg/ml and 0.57 mg/ml respectively. The drug was exposed to acidic and alkaline hydrolysis, oxidation, photo degradation, and dry heat conditioners. The peaks of degradation products were well-resolved from the peak of the standard drug with significantly different values. Statistical analysis proved that the established RP-HPTLC method is reproducible, selective, and accurate for the determination of lornoxicam and thiocolchicoside in its formulations. The method can effectively separate the drug from its degradation products, and it can be considered as stability-indicating assay.

Keywords: Lornoxicam, Thiocolchicoside, Acetonitrile.