Microbiological assay for the determination of meropenem in pharmaceutical dosage form.
Meropenem is a highly active carbapenem antibiotic used in the treatment of a wide range of serious infections. The present work reports a microbiological assay, applying the cylinder-plate method, for the determination of meropenem in powder for injection. The validation method yielded good results and included linearity, precision, accuracy and specificity. The assay is based on the inhibitory effect of meropenem upon the strain of Micrococcus luteus ATCC 9341 used as the test microorganism. The results of assay were treated statistically by analysis of variance (ANOVA) and were found to be linear (r=0.9999) in the range of 1.5-6.0 microg ml(-1), precise (intra-assay: R.S.D.=0.29; inter-assay: R.S.D.=0.94) and accurate. A preliminary stability study of meropenem was performed to show that the microbiological assay is specific for the determination of meropenem in the presence of its degradation products. The degraded samples were also analysed by the HPLC method. The proposed method allows the quantitation of meropenem in pharmaceutical dosage form and can be used for the drug analysis in routine quality control.
Mendez
Andreas S L
AS
Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul, Porto Alegre-RS, Brazil. aslmufrgs@yahoo.com
Weisheimer
Vanessa
V
Oppe
Tércio P
TP
Steppe
Martin
M
Schapoval
Elfrides E S
EE
D000704:Analysis of Variance; D001681:Biological Assay; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004304:Dosage Forms; D000077731:Meropenem; D016982:Micrococcus luteus / Q000187:drug effects; D019999:Pharmaceutical Solutions; D011208:Powders; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013845:Thienamycins / Q000032:analysis* / Q000494:pharmacology*
D004304:Dosage Forms; D019999:Pharmaceutical Solutions; D011208:Powders; D013845:Thienamycins; D000077731:Meropenem