Determination of isepamicin sulfate and related compounds by high performance liquid chromatography using evaporative light scattering detection.
A simple reversed phase high performance liquid chromatographic method was developed for the analysis of isepamicin sulfate. The use of evaporative light scattering detection eliminates the need for sample derivatization. Separation of the isepamicin aminoglycoside from structurally similar related compounds was achieved using two Waters X-Terra RP18 columns connected in tandem at 10 degrees C. The assay of isepamicin sulfate and the estimation of its impurities was accomplished using external standard calibration curves at two sample concentrations: 1.6 mg ml(-1) for the analysis of isepamicin sulfate and 8.0 mg ml(-1) for the estimation of lower level impurities. The limit of detection was 0.1%. The specificity, assay linearity, low level assay linearity and assay repeatability were also investigated.
Vogel
R
R
Schering Plough Research Institute, Kenilworth, NJ 07033, USA.
DeFillipo
K
K
Reif
V
V
D000900:Anti-Bacterial Agents / Q000032:analysis* / Q000737:chemistry; D002236:Carbohydrate Conformation; D002240:Carbohydrate Sequence; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D005839:Gentamicins / Q000032:analysis* / Q000737:chemistry; D008027:Light; D008969:Molecular Sequence Data; D015203:Reproducibility of Results; D012542:Scattering, Radiation; D012680:Sensitivity and Specificity
D000900:Anti-Bacterial Agents; D005839:Gentamicins; C016927:isepamicin