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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 | ID: wpr-460037
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 Index: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacist Year: 2014 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Language: Chinese Journal: China Pharmacist Year: 2014 Type: Article