Method development and validation of meropenem in pharmaceutical dosageform by RP-HPLC

[摘要] An analytical reversed phase HPLC (RP-HPLC) method has been developed and validated for the estimation of meropenem using RP-HPLC column [Inertsil C18 (4.6 mm × 250 mm) 5µ]. The validation parameters has been followed as per FDA and ICH specifications under the study. Water, acetonitrile and methanol have been used as mobile phases in specific composition. The pH of the mobile phase is adjusted with phosphoric acid. The isocratic flow rate of the mobile phase is 1.5 mL/min with UV detection of 300 nm. The method is validated for accuracy, linearity and precision with analytical samples. Moreover, the specificity of the method has determined by the comparison of the drug content in a marketed preparation of meropenem solution. The linearity has been found to be more than 0.999 as well as the precision and accuracy values are less than 2% and from 95% to 105%, respectively. The developed and validated method is found to be the most suitable for quality control programs and can be used as fast, economic, accurate and reproducible." xml:lang="en_US

[学科分类] 化学（综合）

[关键词] Meropenem;RP-HPLC;Method validation;Pharmaceutical dosage form;Article