World Journal of
Pharmaceutical and Life Sciences

EVALUATION AND VALIDATION OF A UPLC METHOD 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. The developed & validated RP?UPLC 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 AMOXYCLAV in combine dosage form.

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