Quantification of cefixime drug substances in pharmaceutical formulations by analytical GC

Venkata Kishore Ch 1, *, Tejeswara Rao V 2, Balaji K 2, Bala Prasad S 3 and Annapurna Nowduri 4

1 Assistant Professor, Department of Chemistry, Dr. L.B College, Visakhapatnam.
2 Assistant Professor Department of Chemistry, MVR College, Visakhapatnam, Andhra Pradesh 530026, India.
3 Professor Department of Civil Engineering, AUCE (A), Visakhapatnam, India.
4 Professor Department of Chemistry, AUCE (A), Visakhapatnam, India.
 
Research Article
Open Access Research Journal of Chemistry and Phar.macy, 2022, 02(02), 001–011.
Article DOI: 10.53022/oarjcp.2022.2.2.0031
Publication history: 
Received on 28 August 2022; revised on 29 September 2022; accepted on 02 October 2022
 
Abstract: 
The present study was conducted to develop and validate an analytical procedure for the determination of cefixime in Pharmaceutical Formulations. The analytical test attributes and evaluated as per the guidelines of ICH Q2 (R1). The method was validated for the determination of Assay in finished products of cefixime and the method validation parameters were evaluated for the analytical test attribute cefixime meets the acceptance criteria. The results obtained were within the specified limits and the samples were analyzed for test item concentration by Gas Chromatography.
 
Keywords: 
Cefixime; Validating the Assay; Gas Chromatography; ICH Q2 (R1)
 
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