RT Journal Article
SR Electronic
T1 Determination of Amantadine Sulfate in Sodium Chloride Injection by Capillary Gas Chromatography
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 138
OP 143
VO 60
IS 3
A1 Yao, Weifeng
A1 Luo, Xuefang
A1 Hu, Yuzhu
YR 2006
UL http://journal.pda.org/content/60/3/138.abstract
AB This paper describes a new method to determine amantadine sulfate in sodium chloride injection by capillary gas chromatography. The chromatographic conditions of the methods employed a SGE BP-1 capillary column (30 m × 0.53 mm i.d., 1.0-μm film thickness); isothermal elution with N2 at a pressure of 100 KPa; injector, oven, and detector temperatures at 220 - °C, 110 °C, and 220 °C, respectively; a split-less mode; and a 1-μL injection volume. Naphthalene was used as the internal standard. Peak purity testing with a Varian Saturn 2200 capillary gas chromatography– mass spectrometry system (Varian, Inc.) equipped with a DB-5 capillary column (30 m × 0.25 mm i.d., 0.25-μm film thickness) was performed for the investigation of specificity. There was a linear relationship between peak area ratios of analyte to the internal standard and concentration of analyte over the concentration range 0.1–2.0 mg/mL. The recovery was 97.8∼00.7%. The relative standard deviation (%) of intermediate precision was less than 0.8. The limits of detection and quantitation were 0.2 μg/mL with a signal-to-noise ratio of 3, and 0.7 μg/mL with a signal-to-noise ratio of 10, respectively. The results of determination were similar to the titration method.