ZHANG Ming-yuan, CHANG Liang, LIU Chang-hai, CHEN Qiu-fen, ZHANG Jun-dong, LU Feng. An improvement method of pre-column derivatization LC-UV for assaying kanamycin in amikacin sulfate injection[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(5): 344-346. doi: 10.3969/j.issn.1006-0111.2013.05.006
| Citation:
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ZHANG Ming-yuan, CHANG Liang, LIU Chang-hai, CHEN Qiu-fen, ZHANG Jun-dong, LU Feng. An improvement method of pre-column derivatization LC-UV for assaying kanamycin in amikacin sulfate injection[J]. Journal of Pharmaceutical Practice and Service, 2013, 31(5): 344-346. doi: 10.3969/j.issn.1006-0111.2013.05.006
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An improvement method of pre-column derivatization LC-UV for assaying kanamycin in amikacin sulfate injection
- 1.
School of Pharmacy, Second Military Medical University, Shanghai 200433, China
- 2.
Shanghai Sine Pharmaceutical Laboratories Co., Ltd, Shanghai 201206, China
- Received Date: 2012-12-17
- Rev Recd Date:
2013-04-08
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Abstract
Objective To develop and evaluate the stable method for the determination of impurity D (kanamycin) in amikacin sulfate injection with pre-column derivatization HPLC. Methods The lower concentration of sample was used. An Agilent ZORBAX SB-C18 column(4.6 mmá150 mm, 5 μm) was used for the chromatographic separations. The mobile phase consisted of mixture of a 2.7% solution of potassium dihydrogen phosphate adjusted to pH 6.5 (using 22 g/L solution of potassium hydroxide) and methanol (30:70, v/v). The flow rate was 1 ml/min. A 50μl volume of each sample was injected. The column temperature was maintained at 30℃. Results The linear range of kanamycin was 2~80 μg/ml (r=0.999 8), accuracy was (93.08±9.65)%. Conclusions The development method was successfully applied to the quantitative determination of kanamycin in amikacin sulfate injection and also offered a new perspective for safety evaluation of amikacin sulfate injection.
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