Main Article Content
Abstract
Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It belongs to the alkylating agent class of chemotherapy drugs, which work by interfering with the DNA inside cells, preventing them from dividing and ultimately leading to the death of cancer cells. In the HPLC analysis, the mobile phase used for the chromatographic runs consisted of methanol, acetonitrile and 0.1 % sodium perchlorate in 65:30:05 (v/v). The separation was achieved on a ProntoSIL C18 (250mm × 4.5 mm; 5µm) column using isocratic mode. Drug peak was well separated and were detected by a UV detector at 234 nm. The method was linear at the concentration range of 5-40 μg/ml for Lomustine. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. LOD and LOQ were found to be 0.04 µg/mL and 0.132 µg/mL for Lomustine. Results confirmed that the method was sensitive and can be useful for the detection and analysis of drugs at very lowest concentrations. Hence it the method reported in the present study was used for the separation and quantification of Lomustine in bulk drug, formulations as well as stability testing.