首页|离子色谱法测定甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠的含量

离子色谱法测定甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠的含量

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目的 建立测定甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠含量的方法。方法 采用离子色谱法,色谱柱为DionexIonPac AS11-HC柱(250 mm × 4。0 mm,5μm),以氢氧化钾溶液为淋洗液,梯度洗脱,流速为1。0 mL/min,柱温为30 ℃,进样体积为25μL。结果 焦亚硫酸钠在10。596~211。920 μg/mL范围内线性关系良好(r=0。999 3),平均回收率100。00%(RSD=1。4%,n=9);硫酸钠在1。027~20。540 μg/mL之间线性关系良好(r=0。999 8),平均回收率99。96%(RSD=1。8%,n=9)。结论 建立的方法简便、准确、灵敏度高,适用于甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠含量的测定。
Content determination of sodium pyrosulfite and sodium sulphate in phentolamine mesylate injection by ion chromatography
Objective To establish a method for the determination of contents of sodium metabisulfite and sodium sulfate in phentolamine mesylate injection.Methods The ion chromatography method with a DionexIonPac AS11-HC(250 mm×4.0 mm,5 pm)column was used,with potassium hydroxide solution as eluent,gradient elution,flow rate of 1.0 mL/min.The column temperature was 30 ℃ and the injection volume was 25 μL.Results Sodium metabisulfite showed good linearity(r=0.999 3)in the range of 10.596-211.920 μg/mL,and its average recovery rate was 100.00%,with an RSD of 1.4%(n=9).Sodium sulfate showed good linearity(r=0.999 8)in the range of 1.027-20.540 μg/mL,and its average recovery rate was 99.96%,with an RSD of 1.8%(n=9).Conclusion The established method is simple,accurate,sensitive and suitable for the determination of sodium metabisulfite and sodium sulfate contents in phentolamine methylate injection.

Ion chromatographyPhentolamine mesylate injectionSodium metabisulfiteSodium sulfateContent determination

王皖、罗时、陈鸿玉、王晓菲、彭飞城、李钰鑫

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湖南省药品检验检测研究院(长沙 410001)

湖南省药品审核查验中心(长沙 410001)

离子色谱法 甲磺酸酚妥拉明注射液 焦亚硫酸钠 硫酸钠 含量测定

2023年国家药品抽检计划项目

2024

中国药师
国家药品监督管理局高级研修学院,武汉医药(集团)股份有限公司

中国药师

CSTPCD
影响因子:0.944
ISSN:1008-049X
年,卷(期):2024.27(4)
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