title: Purity determination of gynalgin bactericidal tablets with HPLC method.
abstract: The study was aimed at developing a simple HPLC method for the determination of the content of impurities in Gynalgin, a two-component preparation. A satisfactory separation was performed on 250 x 4.6 mm Symmetry C8 column in a gradient elution system: mobile phase A--acetonitrile/buffer, pH 5.5 in 10:90, v/v proportion, and mobile phase B--acetonitrile/buffer, pH 5.5 in 75:25 v/v proportion. Two wavelengths: 250 nm and 315 nm were used for detection. Validation confirmed that the method was linear in a required concentration range. The values of correlation coefficients for specific drug substances and the related impurities were as high as 0.999. The results of the purity tests proved that the method was sufficiently selective and precise.
authors.affiliation: Department of Basic and Applied Pharmacy, National Medicines Institute, 30/34 Chelmska St., 00-725 Warszawa, Poland. wbialecka@il.waw.pl
authors.forename: Wanda
authors.initials: W
authors.lastname: Białecka
authors.forename: Anna
authors.initials: A
authors.lastname: Kulik
authors.forename: Marzena
authors.initials: M
authors.lastname: Podolska
authors.forename: Barbara
authors.initials: B
authors.lastname: Kwiatkowska-Puchniarz
authors.forename: Aleksander
authors.initials: A
authors.lastname: Mazurek
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D000890:Anti-Infective Agents / Q000032:analysis* / Q000592:standards; D002021:Buffers; D002138:Calibration; D002750:Chlorquinaldol / Q000032:analysis* / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D004338:Drug Combinations; D004340:Drug Contamination; D006863:Hydrogen-Ion Concentration; D057230:Limit of Detection; D016014:Linear Models; D008795:Metronidazole / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
chemical_list: D000097:Acetonitriles; D000890:Anti-Infective Agents; D002021:Buffers; D004338:Drug Combinations; C078596:Gynalgin; D013607:Tablets; D008795:Metronidazole; D002750:Chlorquinaldol; C032159:acetonitrile