Stability-indicating spectrophotometric methods for the simultaneous determination of Lornoxicam and its oxidative degradation product. application to degradation kinetics and assay of pharmaceutical dosage forms

Stability-indicating simultaneous spectrophotometric methods have been developed for the determination of lornoxicam (LOR) and its oxidative degradation product. To produce the degradation product, LOR was subjected to oxidation using 50% hydrogen peroxide and heating at 80°C for 20 min. Determination of LOR is based on measurement of the zero-order (0D) amplitudes at 373 nm and the first derivative (1D) amplitudes at 406 nm in 0.1 M hydrochloric acid solution where the oxidative degradation product does not show any interference. On the other hand, the oxidative degradation product can be estimated using its first derivative (1D) amplitudes at 305 nm in the same solvent which represents a zero-crossing for LOR. Analytical performance of the proposed spectrophotometric procedures was validated with respect to linearity, range, precision, accuracy, selectivity, detection and quantitation limits. Calibration curves of LOR and its oxidative degradation product were linear in the range 4–24 mg/mL with correlation coefficients not less than 0.9996. The proposed methods were applied for analysis of laboratory-prepared mixtures containing different proportions of the intact drug and its degradation product. Both spectrophotometric 0D373 and 1D406 methods were applied for assay of LOR tablets and vials dosage forms, and they were quantified with recoveries not less than 99.1 %. The described 0D373 and 1D406 were utilized for investigation of LOR oxidative degradation kinetics at different temperatures. The degradation rate constants, half-lives and activation energy were calculated. It was found that the half life of LOR oxidation with 50% hydrogen peroxide at room temperature is about 10.5 hours.