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Determination of content uniformity and dosage distribution of isopromazine hydrochloride tablets in pediatric medicine by high performance liquid chromatography
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Xue-Na ZHAO1, *, Jing SUN2
Laboratory Testing | 2024, 2(8) : 99 - 103
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Laboratory Testing | 2024, 2(8): 99-103
Evaluation and Analysis
Determination of content uniformity and dosage distribution of isopromazine hydrochloride tablets in pediatric medicine by high performance liquid chromatography
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Xue-Na ZHAO1, *, Jing SUN2
Affiliations
  • 1 Jinchang Drug Inspection and Testing Center Jinchang 737100 China
  • 2 Jinchang Central Hospital Jinchang 737100 China
Outline
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Objective To establish a high performance liquidchromatography method for the determination of the content uniformity ofpromethazine hydrochloride, and to provide a reliable experimental basisfor the subsequent study of the content uniformity and content qualityof pediatric drugs after manual breaking tablets. Methods Highperformance liquid chromatography was used, octadecyl silane bondedsilica gel was used as the column filling agent, water (adjusted pH to2.3 with glacial acetic acid)-methanol (55 : 45) was used as the mobilephase, and the detection wavelength was ${254}\mathrm{\;{nm}}$ . ResultsPromethazine hydrochloride showed a good linear relationship in therange of 17.392~26.088 μg/mL, and the linear equation was: $\mathrm{Y}= {55272}\mathrm{X}+{348938}\left({{r}^{2}= {0.9986}}\right)$ . The method recoveryrate was between 100.22% and 101.40%, and the RSD was ${0.49}\%$ . The content uniformity ofpromethazine hydrochloride was in accordance with the provisions of thefour general principles of the Chinese Pharmacopoeia 2020 edition.Finally, this method was used to analyze the accuracy of children’sdrugs by different methods of dosing by the content and contentuniformity of promethazine hydrochloride tablets. Conclusion The method has strong specificity in determining the content uniformity and content of promethazine hydrochloride, and the accuracy and precision are good. The dose accuracy of children’s tablets is reduced by many times of dosing, and it also provides very important data theoretical and practical significance for promoting the dose accuracy of children’s tablets.

high performance liquid chromatography  /  promethazine hydrochloride  /  content uniformity  /  tablet dosing  /  accuracy  /  children's drugs
Xue-Na ZHAO, Jing SUN. Determination of content uniformity and dosage distribution of isopromazine hydrochloride tablets in pediatric medicine by high performance liquid chromatography[J]. Laboratory Testing, 2024 , 2 (8) : 99 -103 .
Year 2024 volume 2 Issue 8
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  • Online Date:2025-07-29
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    1 Jinchang Drug Inspection and Testing Center Jinchang 737100 China
    2 Jinchang Central Hospital Jinchang 737100 China

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*ZHAO Xue-Na, Master, Pharmaceutical Engineer, Jinchang Drug Inspection and Testing Center, Jinchang 737100, 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
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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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