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

[摘要] 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 70:30 %v/v. 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 Methonol:Phosphate buffer mixed in the ratio of 70:30 %v/v. 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. 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 70:30 %v/v. 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 Methonol:Phosphate buffer mixed in the ratio of 70:30 %v/v. 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.

[学科分类] 药学、药理学、毒理学（综合）

[关键词] Symmetry C18;Amoxicillin;Dicloxacillin;RP-HPLC