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Simultaneous Determination of Three Impurities in Trihexyphenidyl Hydrochloride Tablets by GC-MS
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Kang SHI1, Xueyan CHEN2, Junliang DUAN3, Fengyun PAN3, Wenzhi WEI2, *
Pharmacy Today | 2026, 36(4) : 282 - 285
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Pharmacy Today | 2026, 36(4): 282-285
Simultaneous Determination of Three Impurities in Trihexyphenidyl Hydrochloride Tablets by GC-MS
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Kang SHI1, Xueyan CHEN2, Junliang DUAN3, Fengyun PAN3, Wenzhi WEI2, *
Affiliations
  • 1.School of Pharmacy, Qinghai Minzu University, Xining, Qinghai 810016, China
  • 2.Qinghai Provincial Drug Inspection and Testing Institute/NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine (Tibetan Medicine)/Qinghai Provincial Key Laboratory of Modernization of Traditional Chinese and Tibetan Medicine, Xining, Qinghai 810016, China
  • 3.Zhongke Puyan (Beijing) Technology, Beijing 100096, China
Published: 2026-04-25 doi: 10.12048/j.issn.1674-229X.2026.04.006
Outline
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OBJECTIVE

To develop a gas chromatography-mass spectrometry (GC-MS) method for the determination of cyclohexane and potential genotoxic impurities (chlorocyclohexane and 1-cyclohexyl-1-phenylethanol) in trihexyphenidyl hydrochloride tablets.

METHODS

The VF-WAXms capillary column (30 m × 0.25 mm, 1.00 μm) was used. High-purity helium was used as the carrier gas at a flow rate of 2.0 mL·min-1, with a split ratio of 5∶1 and an injection volume of 2 μL. The mass spectrometer was equipped with an electron ionization (EI) source and operated in the selected ion monitoring (SIM) mode for detection.

RESULTS

The results showed that chlorocyclohexane, cyclohexanol, and 1-cyclohexyl-1-phenylethanol exhibited good linear relationships in the range of 25-250 ng·mL-1, with detection limits (LOD) of 10.2, 10.0 and 9.8 ng·mL-1, and quantification limits (LOQ) of 25.4, 25.0 and 24.5 ng·mL-1, respectively. The average recovery rates (n = 6) were 98.93%, 102.93% and 99.97%, respectively.

CONCLUSION

The established method has good specificity and high sensitivity, and can serve as a reference for the quality control of trihexyphenidyl hydrochloride tablets.

GC-MS  /  trihexyphenidyl hydrochloride  /  chlorocyclohexane  /  cyclohexanol  /  1-cyclohexyl-1-phenylethanol
史康, 陈学艳, 段军良, 潘峰云, 魏文芝. GC-MS法同时测定盐酸苯海索片中3种杂质. 今日药学, 2026 , 36 (4) : 282 -285 . DOI: 10.12048/j.issn.1674-229X.2026.04.006
Kang SHI, Xueyan CHEN, Junliang DUAN, Fengyun PAN, Wenzhi WEI. Simultaneous Determination of Three Impurities in Trihexyphenidyl Hydrochloride Tablets by GC-MS[J]. Pharmacy Today, 2026 , 36 (4) : 282 -285 . DOI: 10.12048/j.issn.1674-229X.2026.04.006
Appendix
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Year 2026 volume 36 Issue 4
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Article Info
doi: 10.12048/j.issn.1674-229X.2026.04.006
  • Receive Date：2026-01-08
  • Online Date：2026-09-23
  • Published：2026-04-25
Article Data
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History
  • Received：2026-01-08
Funding
Affiliations
    1.School of Pharmacy, Qinghai Minzu University, Xining, Qinghai 810016, China
    2.Qinghai Provincial Drug Inspection and Testing Institute/NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine (Tibetan Medicine)/Qinghai Provincial Key Laboratory of Modernization of Traditional Chinese and Tibetan Medicine, Xining, Qinghai 810016, China
    3.Zhongke Puyan (Beijing) Technology, Beijing 100096, China
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https://castjournals.cast.org.cn/joweb/jryx/EN/10.12048/j.issn.1674-229X.2026.04.006
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
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Genus		 种数
Number of
species		 占总种数比例
Percentage of total
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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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