NEW SIMPLE STABILITY INDICATING LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF PLAZOMICIN IN BULK DRUG SUBSTANCE AND PHARMACEUTICAL DOSAGE FORMS
Dr. Y. Narasimha Rao*, Kondepati Venkaiah and Dr. M. Prasada Rao
ABSTRACT
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 Plazomicin in pharmaceutical formulations. To assess the effect of method parameters on chromatographic separation of the Plazomicin, 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 ProntoSIL C18 column (250 mm × 4.5 mm; 5μm) at room temperature using Acetonitrile: methanol in the ratio of 75:25 (v/v) in isocratic condition at a flow rate of 1.0 mL/min. The detection was performed by an ultraviolet detector (UVD) at 223 nm with total run time of 10 min. Calibration curves were linear in the concentration range of 20-120 μg/mL for with correlation coefficients of 0.9996. LOD and LOQ were found to be 0.040 μg/mL and 0.132 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 Plazomicin was found to be stable in all the stress degradation conditions. The developed method was able to determine the contents of the Plazomicin commercial dosage forms and hence the method was used for the routine analysis of Plazomicin in bulk drug as well as in pharmaceutical formulations.
Keywords: Plazomicin, HPLC analysis, Method validation, & High-Performance Liquid Chromatography.
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