Application of hydrophilic interaction chromatography for simultaneous separation of six impurities of mildronate substance.
The possibility of separating the impurities of mildronate, an antiischemic drug, by hydrophilic interaction chromatography (HILIC) was investigated on different polar stationary phases (silica, amino, cyano and zwitterionic sulfobetaine). The investigations have shown that HILIC is a useful alternative to reversed phase and ion-pair chromatography. The impact of HILIC separation conditions (acetonitrile content, buffer pH in mobile phase) on retention and selectivity has been systematically studied. Importance of these factors was found to be dependent on the structural properties of solutes. A HILIC method using a zwitterionic sulfobetaine stationary phase was developed and validated to determine six impurities in the drug substance. The method was validated in terms of specificity, limit of quantitation, limit of detection, linearity, accuracy and precision.
Hmelnickis
Juris
J
Joint Stock Company Grindeks, 53 Krustpils Street, Riga LV1057, Latvia. juris hmelnickis@grindeks.lv
Pugovics
Osvalds
O
Kazoka
Helena
H
Viksna
Arturs
A
Susinskis
Igors
I
Kokums
Kaspars
K
D000097:Acetonitriles / Q000737:chemistry; D002021:Buffers; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D004340:Drug Contamination; D006863:Hydrogen-Ion Concentration; D008763:Methylhydrazines / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors; D014867:Water / Q000737:chemistry
D000097:Acetonitriles; D002021:Buffers; D008763:Methylhydrazines; D004364:Pharmaceutical Preparations; D014867:Water; C050147:3-(2,2,2-trimethylhydrazine)propionate; C032159:acetonitrile