World Journal of
Pharmaceutical and Life Sciences

SPIKED FORCE DEGRADATION ASSAY METHOD EVALUATION FOR ESTIMATION OF AMOXYCLAV IN ORAL DOSAGE FORM

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

ABSTRACT

A specific, precise, accurate ultra pressure liquid chromatography (UPLC) method is developed for estimation of amoxicillin and potassium clavulanate in market dosage form. The method employed, with Xterra RP-8 (150mm x 4.6 mm i.d., particle size 5 ?m) in a gradient mode, with mobile phase of KH2PO4: Methanol (80:20). The flow rate was 0.5 ml/min and effluent was monitored at 248 nm. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 250-750 ?g/ml amoxicillin and 62.5-187.5 ?g/ml for potassium clavulanate respectively. The LOD and LOQ values for were found to be 0.0029 (?g/ml) and 0.0091 (?g/ml) for amoxicillin and 0.0052 (?g/ml) and 0.0160 (?g/ml) for potassium clavulanate respectively. No chromatographic interference from excipients and degradants were found. The proposed method was successfully used for estimation of amoxicillin and potassium clavulanate in market dosage form.

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