Original Articles
N. Tamilselvi and A. Rajasekar
Abstract
A stability-indicating, reverse phase high performance liquid chromatographic method for Zolpidem tartrate was developed after forced degradation, the formed degradants were separated on a Enable C18 column with a 35:65% v/v mixture of water containing 0.2% (v/v) triethylamine, (pH was adjusted to 7 with ortho phosphoric acid (OPA) and methanol as mobile phase. The flow rate kept at 1 mLmin−1 and the column effluents were detected at 243 nm. A sharp peak was obtained for Zolpidem tartrate at a retention time of 10.374 min. Forced degradation studies was carried out under acidic, basic, thermal, photolytic and oxidative conditions. Chromatographic peak purity was confirmed as no co-eluting peaks was obtained with the main peaks. One major degradation products from basic hydrolysis was identified and characterized by 1H-NMR, FTIR and mass spectral data. The method was validated as per International Conference on Harmonization guidelines (Q2). Linear regression analysis data for the calibration plot showed good linear relationship between responses in the concentration range of 5 to 25 μg mL−1 with regression coefficient of 0.997. The relative standard deviations for intra and interday precision were below 2%. The formed degradation products was found to be non mutagenic towards Salmonella typhimurium strain TA98 and TA100.