Determination of Residual Toluene in Diclofenac Sodium Raw Material by GC / 中国药师
China Pharmacist
; (12): 1865-1867, 2014.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-460037
Responsible library:
WPRO
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.
Full text:
Available
Database:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacist
Year:
2014
Document type:
Article