Purity determination of gynalgin bactericidal tablets with HPLC method
PBN-AR
Instytucja
Narodowy Instytut Leków
Informacje podstawowe
Główny język publikacji
en
Czasopismo
Acta Poloniae Pharmaceutica - Drug Research
ISSN
0001-6837
EISSN
Wydawca
Polskie Towarzystwo Farmaceutyczne
DOI
Rok publikacji
2013
Numer zeszytu
1
Strony od-do
51-58
Numer tomu
70
Link do pełnego tekstu
Identyfikator DOI
Liczba arkuszy
Słowa kluczowe
en
chlorquinaldol
metronidazole
2-methyl-5-nitroimidazole
2-aminophenol
HPLC method
Streszczenia
Język
en
Treść
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
Inne
System-identifier
PX-56b45b298106eb71826df50b