Next Article in Journal
Previous Article in Journal
Pharmaceutics 2012, 4(3), 334-342; doi:10.3390/pharmaceutics4030334
Article

Development and Validation of a Successful Microbiological Agar Assay for Determination of Ceftriaxone Sodium in Powder for Injectable Solution

 and *
Received: 23 March 2012; in revised form: 22 May 2012 / Accepted: 12 June 2012 / Published: 29 June 2012
View Full-Text   |   Download PDF [151 KB, uploaded 29 June 2012]
Abstract: Ceftriaxone sodium is a cephalosporin with broad-spectrum antimicrobial activity and belongs to the third generation of cephalosporins. Regarding the quality control of medicines, a validated microbiological assay for the determination of ceftriaxone sodium in powder for injectable solution has not been reported yet. This paper reports the development and validation of a simple, accurate and reproducible agar diffusion method to quantify ceftriaxone sodium in powder for injectable solution. The assay is based on the inhibitory effect of ceftriaxone sodium on the strain of Bacillus subtilis ATCC 9371 IAL 1027 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.999) in the selected range of 15.0–60.0 μg/mL, precise with a relative standard deviation (RSD) of repeatability intraday = 1.40%, accurate (100.46%) and robust with a RSD lower than 1.28%. The results demonstrated the validity of the proposed bioassay, which allows reliable ceftriaxone sodium quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine.
Keywords: ceftriaxone sodium; cephalosporins; bioassay; validation ceftriaxone sodium; cephalosporins; bioassay; validation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Export to BibTeX |
EndNote


MDPI and ACS Style

Aléssio, P.V.; Salgado, H.R.N. Development and Validation of a Successful Microbiological Agar Assay for Determination of Ceftriaxone Sodium in Powder for Injectable Solution. Pharmaceutics 2012, 4, 334-342.

AMA Style

Aléssio PV, Salgado HRN. Development and Validation of a Successful Microbiological Agar Assay for Determination of Ceftriaxone Sodium in Powder for Injectable Solution. Pharmaceutics. 2012; 4(3):334-342.

Chicago/Turabian Style

Aléssio, Patrícia V.; Salgado, Hérida R. N. 2012. "Development and Validation of a Successful Microbiological Agar Assay for Determination of Ceftriaxone Sodium in Powder for Injectable Solution." Pharmaceutics 4, no. 3: 334-342.



Pharmaceutics EISSN 1999-4923 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert