Objective: To establish an ion chromatography method for determination of the related substances of amikacin sulfate and its preparation. Methods: A YMC ODS-Aq C18(4.6 mm×250 mm, 5 μm)column was used; the mobile phase was 1 000 mL deionized water containing 20 mL trifluoroacetic acid, 300 μL pentafluoropropionic, 300 μL heptafluorobutyricacid, and 8 mL 50%(v/v) sodium hydroxide solution. The pH was adjusted to 3.3 with 50%(v/v) sodium hydroxide solution. Then 10 mL of acetonitrile was added. The flow rate was 1.0 mL·min-1, the post-column solution was 42 mL·L-1 sodium hydroxide solution and the flow rate was 0.3 mL·min-1. The column temperature was 35 ℃ and the pulsed amperometric detection was adopted. The working electrode was gold electrode (3 mm), with working mode of a four potential waveform. Results: The linear range of amikacin was 0.498-9.969 1 μg·mL-1, the detection limits of amikacin was 2.0 ng.Therelatedsubstances and amikacin could be separated completely. Conclusion: This method is accurate and sensitive, and suitable for the quality control ofamikacin sulfate and its preparation.
LI Qian, LIU Ying
. Determination of related substances of amikacin sulfate and its preparation by ionchromatography[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(3)
: 449
-459
.
DOI: 10.16155/j.0254-1793.2022.03.12
[1] KAWAGUCHI H, NAITO T, NAKAGAWA S, et al. BB-K8, a new semisynthetic amino-glycoside antibiotic[J].J Antibiot, 1972, 25(12):695
[2] 汪复. 氨基糖苷类抗生素的研究进展[J].中国临床药理学杂志, 1991, 7(3):148
WANG F. Research progress of aminoglycoside antibiotics[J].Chin J Clin Pharmacol, 1991, 7(3):148
[3] 齐嵘. 对阿米卡星在临床应用中出现的不良反应的探讨[J].中国现代药物应用, 2015,9(4),73
QI R. To discuss the adverse reactions of amikacin in clinical application[J].Chin J Mod Drug Appl, 2015,9(4):73
[4] 范燕. 65例阿米卡星注射剂不良反应的文献分析[J].中国药物警戒, 2013, 10(12), 740
FAN Y. Literature analysis of 65cases of adverse drug reaction induced by amikacininjection[J].Chin J Pharmacovigil, 2013, 10(12):740
[5] 中华人民共和国药典2010年版.二部[S].2010:388
ChP 2010.VolⅡ[S].2010:388
[6] 中华人民共和国药典2015年版.二部[S].2015:548
ChP 2015.VolⅡ[S].2015:548
[7] 中华人民共和国药典2020年版.二部[S].2020:673
ChP 2020.VolⅡ[S].2020:673
[8] EP 10.0.VolⅡ[S].2019:1815
[9] BP 2020. VolⅠ[S].2020:138
[10] 张凤妹, 王帆, 王建. 非衍生化HPLC法测定硫酸阿米卡星注射液的有关物质和含量[J].中国抗生素杂志, 2014, 39(8):608
ZHANG FM, WANG F, WANG J. The derivatization HPLC determination of the related substance and content of amikacin sulfate and its injection[J].Chin J Antibiot, 2014, 39(8):608
[11] 何丹, 杨林. 柱后衍生化高效液相色谱法测定注射用硫酸阿米卡星[J].药物分析杂志, 2009, 29(6):1025
HE D, YANG L. Dtermination of amikacin sulfate injection by HPLC with post-column derivatization[J].Chin J Pharm Anal, 2009, 29(6):1025
[12] 张明媛, 常靓, 刘长海,等. 柱前衍生化高效液相色谱法检测硫酸阿米卡星注射液中卡那霉素含量的改进[J].药学实践杂志, 2013, 31(5):343
ZHANG MY, CHANG L, LIU CH, et al. An improvement method of pre-column derivatization LC-UV for assaying kanamycin in amikacin sulfate injection[J].J Pharm Pract, 2013, 31(5):343
[13] 王建, 王知坚, 方翠凤. HPLC-ELSD法测定阿米卡星洗剂的含量[J].药物分析杂志, 2009, 29(6):950
WANG J, WANG ZJ, FANG CF. HPLC-ELSD analysis of amikacinlotion[J].Chin J Pharm Anal, 2009, 29(6):950
[14] 吴宏伟, 王珑. HPLC-ELSD法测定硫酸阿米卡星的含量[J].中国药品标准, 2007, 8(3):34
WU HW, WANG L. HPLC-ELSD Determination of amikacin sulfate for injection[J].Drug Stand China, 2007, 8(3):34
[15] 张凤妹, 王建. HPLC-电喷雾检测器测定硫酸阿米卡星中卡那霉素和硫酸盐的含量[J].中国抗生素杂志, 2015, 40(5):354
ZHANG FM, WANG J. The determination of HPLC method for the kanamycin and sulfate inamikacin sulfate using charged aerosol detector[J].Chin J Antibiot, 2015, 40(5):354
[16] ZAWILLA NH, LI B, HOOGMARTENS J, et al. Improved reversed-phase liquid chromatographic method combined with pulsed electrochemical detection for the analysis of amikacin[J].J Pharm Biomed Anal,2007, 43(1):168
