NOVEL STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CAPMATINIB IN BULK DRUG AND PHARMACEUTICAL FORMULATIONS
Dr. M. Prasada Rao* and Nageswararo
ABSTRACT
In the pharmaceutical industry, all manufactured products need to be of the highest quality to ensure the least risk to patients. To guarantee that goods pass certain standards, researchers, manufacturers and developers use various technical equipment and analytical techniques, including liquid chromatography, during the development process. Liquid chromatography is an analytical technique that is used to separate a certain sample into its individual components. HPLC is simple, specific, rapid, precise and accurate; it can be successfully and efficiently adopted for routine quality control analysis of drugs in bulk and pharmaceutical dosage form. In the present study a reverse phase high performance liquid chromatography method was developed and validated for the estimation Capmatinib in pharmaceutical formulations. To assess the effect of method parameters on chromatographic separation of the Capmatinib, statistically designed experiments were performed by varying different method parameters such as buffer concentration, pH of mobile phase, flow rate, and column temperature. The separation was performed on Spherisorb ODS C18 Column (250 x 4.6 mm and 5μm) at room temperature using methanol, acetonitrile and water in the ratio of 60:20:20 (v/v) in isocratic condition at a flow rate of 1.0 mL/min. The detection was performed by a ultraviolet detector (UVD) at 251 nm with total run time of 10 min. Calibration curves were linear in the concentration range of 5-35 μg/mL for with correlation coefficients of 0.9991. LOD and LOQ were found to be 0.033 μg/mL and 0.10 μg/mL proves the sensitivity of the developed method. The method can effectively separate the degradation compounds during the stress study and the standard drug Capmatinib was found to be stable in all the stress degradation conditions. The developed method was able to determine the contents of the Capmatinib commercial dosage forms and hence the method was used for the routine analysis of Capmatinib in bulk drug as well as in pharmaceutical formulations.
Keywords: Capmatinib, HPLC analysis, Mesenchymal-epithelial transition, Method validation and Liquid chromatography.
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