Abstract
CHARACTERIZATION OF FORCE DEGRADATION ASSAY METHOD EVALUATION FOR SIMULTANEOUS ESTIMATION OF AMOXICILLIN AND POTASSIUM CLAVULANATE IN ORAL DOSAGE FORM USING UPLC-MS/MSN

Sumaiya Fatima*, Dr. Osman Ahmed and Dr. Anas Rasheed

ABSTRACT

The method for Reverse Phase Ultra Performance Liquid Chromatography was optimized for Amoxicillin and Potassium Clavulanate by different trials were done by using mobile phase and buffer combination. The mobile phase is a mixture of two solvent systems namely, solvent -A and solvent - B. The solvent– A, contains Trifluroacetic acid. The solvent – B, contains KH2PO4: Methanol (80:20) v/v with gradient flow programming was used as mobile phase. The % RSD values for assays performed in the different laboratories by two analysts were found to be on (Acquity UPLC Waters, 2695H) instrumentation - 1 (0.03% and 0.04%) on (Agilent Technologies, 1290) instrumentation – 2 (0.03% and 0.02%) did not exceed 2, indicating the ruggedness of the method. LOD and LOQ were determined by injecting progressively lower concentrations of two drugs. The LOD of Amoxicillin and Potassium Clavulanate were found to be 0.0029 μg/mL and 0.0052 μg/mL respectively. The LOQ of Amoxicillin and Potassium Clavulanate were found to be 0.0091 μg/mL and 0.0160 μg/mL respectively. Assay studies for the analysis of formulation was performed and was found to be satisfactory with 99.28% and 99.41% purity of percentage for Amoxicillin and Potassium Clavulanate. The developed & validated RP‐UPLC-MSMSn methods employed here proved to be specific, fast, precise and accurate for the simultaneous estimation and stability indicating assays as well as related substance quantifications of Amoxicillin and Potassium Clavulanate in combine dosage form.

Keywords: RP?UPLC-MSMSn, combine dosage form, Amoxicillin and Potassium Clavulanate.


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