Analytical Method Development and Validation of Amoxicillin and Dicloxacillin in API and its Dosage Form by RP-HPLC

Abstract

Background Amoxicillin and dicloxacillin are the antibiotics useful for the treatment of a number of bacterial infections constituting the first line of treatment for middle ear infections. It may also be used for Strep throat pneumonia skin infections and urinary tract infections. They are taken by mouth or less commonly in injection form.Objective The main objective of the simultaneous estimation of Amoxicillin and Dicloxacillin was to establish identity purity physical characteristics and potency of the drugs.Methodology The estimation of Amoxicillin and Dicloxacillin was done by Reversed-phase- High performance liquid chromatography RP-HPLC. The phosphate buffer had a pH of 4.6 and the mobile phase was optimized consisting of Methanol Phosphate buffer mixed in the ratio of 7030 vv. A Symmetry C18 4.6 x 150 mm 5 mm Make XTerra column was used as stationary phase.Results The results were in good agreement with those obtained with official HPLC with maximum absorption using mobile phase which was optimized consisting of MethonolPhosphate buffer mixed in the ratio of 7030 vv. A Symmetry C18 4.6 x 150 mm 5 mm Make XTerra column was used as stationary phase. According to ICH guidelines all the data were achieved with good precision accuracy and robustness.Conclusion On the basis of results of assay and validation parameters it can be concluded that the proposed method was simple fast accurate and precise. It is possible to estimate Amoxicillin and Dicloxacillin dosage forms simultaneously in a combination capsule dosage form that can be used on a regular basis.