A Novel Validated Eco-friendly RP-UHPLC Method for Assay and Related Substances in Meropenem

Kaniti, Tirumala Rao; L, Vaikunka Rao; Kandepi, V. V. Krishna Mohan

Abstract

A simple, rapid, sensitive, specific, eco-friendly and stability-indicating linear gradient liquid chromatographic method (RP-UHPLC) for simultaneous estimation of assay and its related compounds in Meropenem API samples is developed and validated. Chromatographic separation was achieved on Zorbax Eclipse plus C18, (100 x 4.6) mm, 3.5 µm RRLC short column and 10 mM potassium dihydrogen orthophosphate is used as buffer, buffer solution used as eluent A and buffer and acetonitrile combination 30: 70 v/v ratio used as eluent B and Agilent RRLC (UHPLC) system is used for analysis. The mobile phase flow rate was 1.0 ml/min, and the eluted compounds were monitored at 220 nm for related substance method and 290 nm for assay method. Excellent resolution was obtained between Meropenem and its related compounds which were eluted within 10 min. The correlation co-efficient(r) is > 0.995 for both the methods from linearity data and percentage of recovery is 98.0 to 102.0 and 80.0 to 120.0 % for assay method and for related substance method respectively. Sensitivity of the method is found to be less than 0.316 µg/ml. Peak homogeneity data for Meropenem in the chromatograms from the stressed samples were obtained by using photodiode array detector demonstrated the specificity of the method for analysis of Meropenem in presence of the degradation compounds. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, and robustness.


Keyword(s)

Meropenem, Related substances, Assay, Method development, Validation, UHPLC, RRLC

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