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Titolo:
Development and validation of a high-performance liquid chromatographic stability-indicating method for the analysis of Synercid (R) in quality control, stability and compatibility studies
Autore:
Vasselle, B; Gousset, G; Bounine, JP;
Indirizzi:
RhoneDev,lenc Rorer, Res & Dev, Chem & Pharmaceut Dev, Pharmaceut Sci,ProdRhone Poulenc Rorer Antony France F-92165 aceut Dev, Pharmaceut Sci,Prod
Titolo Testata:
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
fascicolo: 5, volume: 19, anno: 1999,
pagine: 641 - 657
SICI:
0731-7085(199904)19:5<641:DAVOAH>2.0.ZU;2-2
Fonte:
ISI
Lingua:
ENG
Soggetto:
STAPHYLOCOCCUS-AUREUS; RP 59500; QUINUPRISTIN/DALFOPRISTIN; PARAMETERS; RUGGEDNESS; RP-59500; DESIGN;
Keywords:
HPLC; method validation; robustness; experimental design; streptogramin; antibiotic; quinupristin; dalfopristin; Synercid (R);
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
18
Recensione:
Indirizzi per estratti:
Indirizzo: Bounine, JP RhoneDev,lenc Rorer, Res & Dev, Chem & Pharmaceut Dev, Pharmaceut Sci,Prod Rhone Poulenc Rorer 20 Rue Raymond Aron Antony France F-92165
Citazione:
B. Vasselle et al., "Development and validation of a high-performance liquid chromatographic stability-indicating method for the analysis of Synercid (R) in quality control, stability and compatibility studies", J PHARM B, 19(5), 1999, pp. 641-657

Abstract

A gradient high-performance liquid chromatographic (HPLC) method was developed for the analysis of Synercid(R) freeze-dried powder in routine qualitycontrol, stability and compatibility studies. This method is suited for a simultaneous assay of drug substances and impurities. The method was validated for precision, reproducibility, linearity, accuracy and limits of detection. The robustness study that was performed according to an experimental design is described. (C) 1999 Elsevier Science B.V. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/09/20 alle ore 23:34:48