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Study on in-line monitoring of water content in domperidone tablets particles by near infrared spectroscopy*
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Xiao-liang WANG**, Long-qing NIU, Bing-hua ZHANG**
Chinese Journal of Pharmaceutical Analysis | 2024, 44(11) : 1923 - 1931
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(11): 1923-1931
Process Evaluation • Standard Deliberation
Study on in-line monitoring of water content in domperidone tablets particles by near infrared spectroscopy*
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Xiao-liang WANG**, Long-qing NIU, Bing-hua ZHANG**
Affiliations
  • Shaanxi Institute for Food and Drug Control,Xi’an 710065,China
Published: 2024-12-01 doi: 10.16155/j.0254-1793.2023-0357
Outline
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Objective:

To establish a quantitative model to in-line in situ determination of the water content of domperidone tablets particles in fluidized bed granulation drying process.

Methods:

Using micro near infrared spectrometer,in-line collected near infrared(NIR) spectrum of domperidone tablets particles in granulation drying process,took sample at different drying time to acquire sample in different level of water content. The pretreatment method of first derivative(FD),multiplicative scatter correction (MSC) and Savitzky-Golay smoothing were selected. The modeling band was 1 100-1 600 nm,model was established by partial least square(PLS) method,and validation was executed including accuracy,precision,specificity,linearity and range,robustness.

Results:

The root mean square error of cross validation(RMSECV) was 0.079 7,the coefficient of determination(R2) was 0. 994 5,the root mean square error of prediction(RMSEP) was 0.092 3,the R2 was 0.986 0. All validation results met predefined criteria.

Conclusion:

It is feasible for using micro NIR spectrometer to in-line measure the water content of domperidone tablets particles which provides an experimental basis for the in-line application of process analysis technology in pharmaceutical industry.

domperidone tablets  /  particle  /  water content  /  near infrared spectroscopy  /  process analysis
Xiao-liang WANG, Long-qing NIU, Bing-hua ZHANG. Study on in-line monitoring of water content in domperidone tablets particles by near infrared spectroscopy*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (11) : 1923 -1931 . DOI: 10.16155/j.0254-1793.2023-0357
Year 2024 volume 44 Issue 11
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Article Info
doi: 10.16155/j.0254-1793.2023-0357
  • Online Date:2026-03-18
  • Published:2024-12-01
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  • Revised:2024-03-29
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    Shaanxi Institute for Food and Drug Control,Xi’an 710065,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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