Development and validation of a high-performance liquid chromatographic stability-indicating method for the analysis of Synercid in quality control, stability and compatibility studies.
A gradient high-performance liquid chromatographic (HPLC) method was developed for the analysis of Synercid freeze-dried powder in routine quality control, 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.
Vasselle
B
B
Rhône-Poulenc Rorer, Research and Development, Antony, France.
Gousset
G
G
Bounine
J P
JP
D000900:Anti-Bacterial Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D003627:Data Interpretation, Statistical; D004340:Drug Contamination; D005612:Freeze Drying; D007202:Indicators and Reagents; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D014769:Virginiamycin / Q000032:analysis*
D000900:Anti-Bacterial Agents; D007202:Indicators and Reagents; D014769:Virginiamycin; C062940:quinupristin-dalfopristin