Determination of Residual Toluene in Diclofenac Sodium Raw Material by GC
- VernacularTitle:气相色谱法测定双氯芬酸钠原料中的甲苯残留
- Author:
Huiying LIU
;
Rui GAO
- Publication Type:Journal Article
- Keywords:
GC;
Residual organic solvents;
Toluene;
Internal standard method;
Diclofenac sodium
- From:
China Pharmacist
2014;(11):1865-1867
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a detection method for residual toluene in diclofenac sodium raw material by GC. Methods:An HP-5 column (0. 53 mm × 30 m, 2. 65 μm) with nitrogen as the carrier gas was employed for the separation. The temperature of the column, injection port and FID detector was set at 50℃, 200℃ and 250℃, respectively. An internal standard method with isooctane as the internal standard was used to assay the residual amount after the sample was dissolved in DMSO. Results:The linear calibration curve was obtained over the range of 9. 27-111. 19μg·ml-1(r=0. 999 4). The mean recovery was 97. 27%(RSD=2. 80%,n=9). The LOD and LOQ was 0. 59μg·ml-1 and 1. 46μg·ml-1 , respectively. The residual contents of toluene in 3 batches of the products all met the relevant regulations. Conclusion:The established method is reliable and accurate, and can be used in the quality control of diclofenac sodium.
