A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to beta-lactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 µg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine.
Main Authors: | Manfio,Maria Luisa, Agarrayua,Danielle Araújo, Machado,Jaison Carlosso, Schmidt,Cleber Alberto |
---|---|
Format: | Digital revista |
Language: | English |
Published: |
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
2013
|
Online Access: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000400015 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Similar Items
-
A fully validated microbiological assay for daptomycin injection and comparison to HPLC method
by: Christ,Ana Paula, et al.
Published: (2015) -
Development and validation of a rapid turbidimetric assay to determine the potency of norfloxacin in tablets
by: Chierentin,Lucas, et al.
Published: (2015) -
A fully validated assay for the analysis of aminoglycoside antibiotics in milk and kidney
by: RIKILT -
SIMULTANEOUS DETERMINATION OF CEFTRIAXONE SODIUM AND STATIN DRUGS IN PHARMACEUTICAL FORMULATIONS AND HUMAN SERUM BY RP-HPLC
by: SULTANA,NAJMA, et al.
Published: (2010) -
CHEMICAL STABILITY OF CEFTRIAXONE BY A VALIDATED STABILITY-INDICATING LIQUID CHROMATOGRAPHIC METHOD
by: DE DIEGO,M, et al.
Published: (2010)