Determination of the Content and Related Substances of Paromomycin Sulfate by HPLC Combined with Pulsed Amperometric Detection Using a Pentafluorophenyl Column
1. School of Food Science and Pharmaceutical Engineering, Nanjing Normal University, Nanjing 210023, China;
2. Jiangsu Institute for Food and Drug Control, Nanjing 210008, China;
3. NMPA Key Laboratory for Impurity Profile of Chemical Drugs,Nanjing 210008, China;
4. School of Pharmacy, Shanghai Jiaotong University,Shanghai 200240, China
OBJECTIVE To establish a high performance liquid chromatography-pulsed amperometric electrochemical detector(HPLC-PAD) method for the direct determination of paromomycin sulfate raw material. METHODS The separation was performed on Agilent® Pursuit PFP(4.6 mm×250 mm, 5 μm). The mobile phase consisted of 2.0%(V/V) trifluoroacetic acid solution [containing 0.15%(V/V) pentafluoropropionic acid, adjusted to pH 3.5 with 50% sodium hydroxide(W/W)] to determine the substances related to paromomycin sulfate with the four-potential waveform of an integrated pulse amperometric electrochemical detector. RESULTS The established HPLC-PAD method using pentafluorophenyl column, was more suitable for the analysis of polar substances than octadecylsilane bond and silica gel filled column. Twteney-one peaks were separated, including paromomycin Ⅱ and its isomer paromomycin I and 19 other impurities. In the range of 0.49-118.30 μg·mL-1, the concentration of paromomycin showed a good linear relationship with the peak area(r>0.999 3). The limit of detection(LOD) was 0.49 μg·mL-1, the limit of quantitation(LOQ) was 0.99μg·mL-1, and the RSDs of repeatability and precision were less than 2.0%. CONCLUSION The developed HPLC-PAD method has good specificity, sensitivity, stability, and durability, providing a reliable analytical means for the quality control and process optimization of paromomycin.
耿月, 朱晓玥, 周小华, 陈舟舟, 朱永强, 袁耀佐. 五氟苯基柱HPLC-PAD法测定硫酸巴龙霉素含量及有关物质[J]. 中国药学杂志, 2022, 57(16): 1380-1386.
GENG Yue, ZHU Xiao-yue, ZHOU Xiao-hua, CHEN Zhou-zhou, ZHU Yong-qiang, YUAN Yao-zuo. Determination of the Content and Related Substances of Paromomycin Sulfate by HPLC Combined with Pulsed Amperometric Detection Using a Pentafluorophenyl Column. Chinese Pharmaceutical Journal, 2022, 57(16): 1380-1386.
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2022, Vol. 57 
