FORCED DEGRADATION STUDIES AND DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC CHROMATOGRAPHIC METHOD FOR TETRAZEPAM ASSAY AND RELATED SUBSTANCES

Nilesh Prajapati*, Mayank Dalal and Hasumati A. Raj

ABSTRACT

Tetrazepam (TZP) is 7-Chloro-5-cyclohex-1-en-1-yl-1-methyl-1, 3-dihydro-2H-1,4-benzodiazepin-2-one, its available as muscle relaxant. In this study, degradation behavior of Tetrazepam was studied by subjecting the drug to various ICH stress conditions. Also a new, simple, sensitive and accurate stability-indicating methods were established for quantitative determination of Tetrazepam in the presence of various and related compounds (Impurity I, II and III). An expectable separation was achieved with ODS C18 column with flow rate 1.0 ml/min. UV Detection wavelength was used for estimation of Tetrazepam over a concentration range of 5 – 300 μg/ml with mean recovery of 99.23 – 101.78 %. Methods can analysis Tetrazepam related compound LOQ limit up to 0.016 μg/ml. Method can well resolve all degraded product as compare to Tetrazepam. Developed method can routinely used for the estimation of Tetrazepam related compounds from the dosage form and also for stability sample.

Keywords: Tetrazepam, related compounds, stability indicating, HPLC, Tablet.