Two simple, accurate, precise procedures have been developed for the simultaneous estimation of tapentadol hydrochloride (TAP) and lornoxicam (LOR) in combined synthetic mixture. The first method was based on employing simultaneous equation method for analysis of both drugs. Tapentadol hydrochloride and lornoxicam have shown absorbance maxima at 217 and 265 nm in methanol, respectively. The second method was based on derivative spectrophotometric method involving the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectrum was obtained in methanol and the determinations were made at 267.4 nm (ZCP of lornoxicam) for tapentadol hydrochloride and 343.0 nm (ZCP of tapentadol hydrochloride) for lornoxicam. The linearity was obeyed in the concentration range of 8-36 μg/ml for tapentadol hydrochloride and 4-28 μg/ml for lornoxicam. Both methods were validated statistically and recovery studies were carried out. The methods were successfully applied to synthetic mixture because no interference from the mixture excipients was found. The suitability of this method for the quantitative determination of tapentadol hydrochloride and lornoxicam was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of tapentadol hydrochloride and lornoxicam in combination. The results of analysis have been validated statistically and by recovery studies. The validation study is statistically significant as all statistical parameter are within the acceptance range (% RSD < 2.0 and S.D. < 2.0) for both accuracy and precision.
Loading....