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Determination of epichlorohydrin in Metoprolol Succinate Tablets by gas chromatography-mass spectrometry
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Lan-Bo DUAN1, Chun-Yan LIANG2, Li-Li HUANG3, *
Laboratory Testing | 2024, 2(12) : 1 - 5
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Laboratory Testing | 2024, 2(12): 1-5
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Determination of epichlorohydrin in Metoprolol Succinate Tablets by gas chromatography-mass spectrometry
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Lan-Bo DUAN1, Chun-Yan LIANG2, Li-Li HUANG3, *
Affiliations
  • 1 Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd. Shenzhen 518000 China
  • 2 Guilin Medical University Guilin 541000 China
  • 3 Guangxi Zhuang Autonomous Region Institute for Drug Control Nanning 530001 China
Published: 2024-12-08
Outline
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Objective To establish a gas-mass spectrometry method for determination of epichlorohydrin in Metoprolol succinate tablets. Methods The chromatographic column is HP-1MS. Injection temperature is${220}^{\circ }\mathrm{C}$; The injection method is split injection, and the split ratio is${10}: 1$. The heating procedure is to keep the initial temperature at${50}^{\circ }\mathrm{C}$for$3\mathrm{\;{min}}$, then raise the temperature to${80}^{\circ }\mathrm{C}$at a rate of${20}^{\circ }\mathrm{C}/\mathrm{{min}}$for$5\mathrm{\;{min}}$, and to${280}^{\circ }\mathrm{C}$at a rate of${40}^{\circ }\mathrm{C}/\mathrm{{min}}$for$8\mathrm{\;{min}}$. The sample intake capacity is${1\mu }\mathrm{L}$. The ion source is electron bombardment source (EI), ion source temperature is${230}^{\circ }\mathrm{C}$. Mass spectrometry interface temperature is${260}^{\circ }\mathrm{C}$; the monitoring mode of mass spectrometry is SIM. The mass to charge ratios (m/z) are 49, 57 and 62. Results The linear range of epichlorohydrin concentration is${30}\sim {120}\mathrm{{ng}}/\mathrm{{mL}}\left({r >{0.99}}\right)$. The detection limit is${32.37}\mathrm{{ng}}/\mathrm{{mL}}$. The limit of quantitation is${107.89}\mathrm{{ng}}/\mathrm{{mL}}$. RSD of precision is${1.8}\%\left({n = 6}\right)$. The average recovery is${103.8}\%$with RSD of${2.5}\%\left({n = 6}\right)$. Epichlorohydrin was not detected in 3 batches of Metoprolol succinate tablets. Conclusion The established gas-mass coupling method is simple, practical, accurate and reliable, and can be used for the determination of epichlorohydrin in Metoprolol succinate tablets.

GC-MS method  /  Metoprolol  /  epichlorohydrin
Lan-Bo DUAN, Chun-Yan LIANG, Li-Li HUANG. Determination of epichlorohydrin in Metoprolol Succinate Tablets by gas chromatography-mass spectrometry[J]. Laboratory Testing, 2024 , 2 (12) : 1 -5 .
Year 2024 volume 2 Issue 12
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  • Online Date:2025-07-28
  • Published:2024-12-08
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Affiliations
    1 Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd. Shenzhen 518000 China
    2 Guilin Medical University Guilin 541000 China
    3 Guangxi Zhuang Autonomous Region Institute for Drug Control Nanning 530001 China

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*HUANG Li-Li, Master, Associate Senior Pharmacist, Guangxi Zhuang Autonomous Region Institute for Drug Control, Nanning 530001, China. E-mail:
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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