ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR ESTIMATION OF MEROPENEM AND VABORBACTAM IN SYNTHETIC MIXTURE
Journal: International Journal of Advanced Research (Vol.7, No. 3)Publication Date: 2019-03-01
Authors : Upasana K patel; Jaymin Ganshyambhai patel Sharda.;
Page : 865-871
Keywords : Meropenem Vaborbactam Stability indicating RP-HPLC Method Validation.;
Abstract
A Simple, Rapid, Economical, Precise And Accurate Stability Indicating RP-HPLC Method for Simultaneous Estimation of Meropenem and Vaborbactam in their Combined Dosage Form has been Developed. A Reverse Phase High Performance Liquid Chromatographic Method was Developed for the Simultaneous Estimation of Meropenem and Vaborbactam. In Their Combined Dosage Form has been Developed. The Separation was Achieved by LC- 20 AT C18 (250mm x 4.6 mm x 2.6 ?m) column and Buffer (pH 6) : Methanol (70:30) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 242 nm. Retention time of Meropenem and Vaborbactam were found to be 4.227 and 5.413 min, respectively. The method has been validated for Linearity, Accuracy and Precision. Linearity Observed for Meropenem 10-30 μg/ml and for Vaborbactam 10-30 μg/ml. Developed method was found to be Accurate, Precise and Rapid for Simultaneous estimation of Meropenem and Vaborbactam in their combined dosage form. The Drug was Subjected to Stress Condition of Hydrolysis, Oxidation, Photolysis and Thermal Degradation, Considerable Degradation was Found in Alkaline Degradation. The Proposed Method was Successfully Applied for the Simultaneous Estimation of Both the Drugs in Combined Dosage Form.
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