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Identification of the related substances in penciclovir cream by two-dimensional LC-MS techniques*
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Abbosova Zokirjonovna Diyorakhon, Li-jie WANG, Yu-ting LU, Min SONG, Tai-jun HANG**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(1) : 89 - 100
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(1): 89-100
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Identification of the related substances in penciclovir cream by two-dimensional LC-MS techniques*
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Abbosova Zokirjonovna Diyorakhon, Li-jie WANG, Yu-ting LU, Min SONG, Tai-jun HANG**
Affiliations
  • Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China
Published: 2024-01-31 doi: 10.16155/j.0254-1793.2024.01.09
Outline
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Objective:

To identify the structures of the related substances in penciclovir cream by two-dimensional liquid chromatography quadrupole time-of-flight tandem mass spectrometry (2D-LC-Q TOF/MS) technique.

Methods:

The first-dimension separation of the related substances in penciclovir cream and its stressed samples according to ICH were carried out on an ODS (250 mm×4.6 mm, 5 μm) column with gradient elution by 0.15% formic acid 10 mmol·L-1 ammonium formate buffer solution and acetonitrile as mobile phases, and each related substance was enriched separately. The second-dimension gradient elution was performed on a Phenomenex Luna SCX (250 mm×4.6 mm, 5 μm) column with 0.1% formic acid 20 mmol·L-1 ammonium formate buffer solution and acetonitrile as mobile phases for each of the related substances to achieve good separation with the matrix of penciclovir cream. The accurate mass and elemental composition of the parent ions and their product ions of the related substances were determined by positive electrospray-ionization quadrupole time-of-flight high resolution mass spectrometry, and the structures of all the related substances were elucidated.

Results:

Under the established 2D-LC-Q TOF/MS analytical conditions, penciclovir and its related substances were adequately separated, and 21 major related substances were detected and identified in the penciclovir cream and its stressed samples. According to their chromatographic retention behavior, spectral characteristics, mass spectrometry characteristics and their differences from other known related substances of nucleoside drugs and combing with synthesis and formulation process route, their structures can be identified all of which were identified for the first time.

Conclusion:

The results can provide reference for the quality control of penciclovir cream.

penciclovir cream  /  related substances  /  structural identification  /  stressed degradation  /  2D-LC-Q TOF/MS
Abbosova Zokirjonovna Diyorakhon, Li-jie WANG, Yu-ting LU, Min SONG, Tai-jun HANG. Identification of the related substances in penciclovir cream by two-dimensional LC-MS techniques*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (1) : 89 -100 . DOI: 10.16155/j.0254-1793.2024.01.09
Year 2024 volume 44 Issue 1
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Article Info
doi: 10.16155/j.0254-1793.2024.01.09
  • Receive Date:2023-05-11
  • Online Date:2026-03-16
  • Published:2024-01-31
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  • Received:2023-05-11
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    Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China
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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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