Determination of 10 Residual Organic Solvents in Norvancomycin Hydrochloride Raw Material by HS-GC
10.6039/j.issn.1001-0408.2015.21.35
- VernacularTitle:顶空气相色谱法测定盐酸去甲万古霉素原料药中的10种有机溶剂残留量Δ
- Author:
Wenfei GENG
;
Minghao ZUO
;
Xiaonan ZHANG
;
Mi TANG
;
Xuexia ZHANG
;
Jie TONG
- Publication Type:Journal Article
- Keywords:
Norvancomycin hydrochloride;
Macroreticular resin;
Residual solvents;
Headspace gas chromatography
- From:
China Pharmacy
2015;(21):2977-2979
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish the method for determining 10 residual organic solvents in norvancomycin hydrochloride raw material. METHODS:Headspace gas chromatography was performed on the column of nitro modified polyethylene terephthal-ate glycol as stationary phase capillary column;the oven temperature program started at 40 ℃ for 3 min and increased at a rate of 8 ℃/min up to 150 ℃ for 10 min;the temperature was 200 ℃ with carrier gas of high-purity nitrogen gas,the constant flow rate was 5 ml/min with split ratio of 15∶1;the headspace vial equilibrium temperature was 85 ℃ with equilibrium time of 40 min,and the volume was 1 ml. RESULTS:The concentration of n-pentane,acetone,ethanol,benzene,acrylonitrile,toluene,xylene,chlo-robenzene,styrene,divinylbenzene had good linear relationship with its peak area values(r=0.995 7-0.999 9);the RSDs of preci-sion,repeatability tests was ≤6.6%;average recovery was in the range of 94.3%-106.6%(RSD=0.5%-4.5%,n=9). CONCLU-SIONS:The method is fast,sensitive and accurate,and can be used for the determination of residual organic solvents in norvanco-mycin hydrochloride raw material.
