LC methods for acyclovir and related impurities determination.
Acyclovir, guanine, and impurity A have been baseline separated with isocratic conditions at pH=3.0 and run time under 15 min by employing a SB-CN column from Agilent (150 mm x 4.6mm and 3.5 microm). Moreover, when run time was increased to 40 min six impurities (guanine, impurities A, F, G, Vir 3/4 and N(7)) plus acyclovir were separated in the same conditions. The mobile phase consisted of buffer A/acetonitrile 96:4 (v/v), being buffer A:25 mM H(3)PO(4) (Milli-Q H(2)O) brought to pH 3.0 with KOH. The same column provided separation for all the seven impurities described in pharmacopoeia, including impurity C, which coeluted with acyclovir in the previous conditions with a mobile phase prepared with 25 mM phosphoric acid (pH=1.8)/acetonitrile 96:4 (v/v). The method has been validated following ICH guidelines and it has demonstrated to be reliable for acyclovir and its impurities determination.
Huidobro
A L
AL
Sección de Química Analítica, Facultad de CC Experimentales y de la Salud, Urbanización Montepríncipe, 28668 Boadilla del Monte, Madrid, Spain.
Rupérez
F J
FJ
Barbas
C
C
D000212:Acyclovir / Q000032:analysis*; D000998:Antiviral Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004355:Drug Stability; D006147:Guanine / Q000032:analysis; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D012015:Reference Standards; D015203:Reproducibility of Results; D013607:Tablets
D000998:Antiviral Agents; D007202:Indicators and Reagents; D013607:Tablets; D006147:Guanine; D000212:Acyclovir