HPLC determination of amoxicillin granules and its related substances.docVIP

 PAGE \* MERGEFORMAT 13 HPLC determination of amoxicillin granules and its related substances Study: Hong Jianwen Wang Yan Li Chang Butterfly Fun [Abstract] Objective To establish the amoxicillin granules determination of amoxicillin and related substances. Methods to octadecyl silane bonded silica as a filler to 0.05 mol / L potassium dihydrogen phosphate solution (pH value of 5.0 acetonitrile (volume ratio of 97.5:2.5 for the determination of the mobile phase and 0.05 mol / L potassium dihydrogen phosphate solution (pH 5.0 acetonitrile (volume ratio of 99:1 as mobile phase A, 0.05mol / L potassium dihydrogen phosphate solution (pH5.0 acetonitrile (volume ratio of 80:20 as mobile phase B, inspection of the material gradient elution, detection wavelength 230 nm, column temperature 30 , the flow rate 1.0 mL / min. Results amoxicillin at 0.1 ~ 1 mg / mL (r = 0.999 9, n = 7) and 0.049 ~ 0.0012 mg / mL (r = 0.999 8, n = 5) in the range of linear relationship between peak area good, low, middle and high recovery rate of three concentrations were 100.2%, 99.8% and 100.0% (RSD = 0.2%, n = 9). amoxicillin related substances detection limit was 2 ng, and the principal components and related substances are effective separation. Conclusion The established content Determination of rapid, accurate and reproducible method for related substances specific, sensitive, amoxicillin granules can be used for quality control. [Keywords:] determination of amoxicillin granules related substances by high performance liquid chromatography Amoxicillin granules Federal Pharmaceutical Co., Ltd. of Hong Kong, is broad-spectrum semi-synthetic penicillin antibiotics, with good effect, not easy to cause allergies, etc., are widely used in children’s respiratory system, urogenital system, digestive system infections. A Moxi Lin granule existing quality standards for imported drug registration standards. The standard by less selective, influencing factors, reagents and certain toxic