1School of Life Sciences, Punyashlok Ahilyadevi Holkar Solapur University, Solapur - 413255, Maharashtra, India
2Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola - 413307, Solapur, Maharashtra, India
3Department of Pharmaceutical Chemistry, SPM’s College of Pharmacy, Akluj-413101, Malshiras, Solapur, Maharashtra, India
Carmustine is a nonspecific antineoplastic agent that belongs to the nitrosourea group of compounds (bischloro-ethyl nitrosourea) and has various mechanisms of tumor cytotoxicity. Carmustine stress degradation can be studied using UV spectrophotometry. According to the International Conference on Harmonization (ICH) criteria, carmustine was tested to various stress conditions. A stability-indicating UV spectroscopic approach was devised for drug analysis in the presence of degradation products. Stress degradation study was performed in alkaline, acidic, neutral and photolytic conditions. Linearity was observed for 0.50-2.50μg/ml drug concentration in ethanol at 231nm with the correlation coefficient 0.9986. Precision investigations were conducted intra-day and inter-day. For intra-day and inter-day precision experiments, the relative standard deviations were found to be 0.0042 and 0.0110, respectively. In acidic, alkaline, photolytic, and oxidative stress conditions, carmustine was shown to be degraded, however it was found to be stable in neutral condition. LOD and LOQ were observed to be 3.088μg/ml and 9.358μg/ml in ethanol respectively. The decrease in absorbance was noticed, indicating that the carmustine was degrading under acidic, alkaline and photolytic stress conditions. In photolytic circumstances, the carmustine was observed to be more unstable. The procedure was found to be convenient and cost-effective. This method can be used to study carmustine stress degradation behavior in small industries where high-end instruments are not accessible.
Carmustine, UV Spectroscopy, ICH Guidelines, Stress Degradation, Glioma