Sample Mass Estimate for the Use of Near-Infrared and Raman Spectroscopy to Monitor Content Uniformity in a Tablet Press Feed Frame of a Drug Product Continuous Manufacturing Process

Hetrick, Evan M.; Shi, Zhenqi; Harms, Zachary D.; Myers, David P.

doi:10.1177/0003702820950318

Cited by 8 publications

(1 citation statement)

References 24 publications

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“…This technique has been applied by the World Health Organization (WHO), the State Food and Drug Administration of China (SFDA) as a strategic plan for the quality assessment of TCM [9,10], and got increasing concerns because it focuses on the characterization of the total sample composition. Several ways, for instance, high-performance thin layer chromatography (HPTLC) [11][12][13][14], thin-layer chromatography (TLC) [15][16][17], infrared spectroscopy (IR) [18][19][20], mass spectrometry (MS) [21,22], gas chromatography (GC) [23,24], high-performance liquid chromatography (HPLC) [25][26][27], nuclear magnetic resonance (NMR) [28][29][30][31] and high-performance liquid chromatography (UPLC) [32][33][34] are utilized for fingerprinting to characterize multiple compounds in the tested herbal samples. Among the abovementioned methods, HPLC is generally the most applied method for its high sensitivity, selectivity, and low cost [35].…”

Section: Introductionmentioning

confidence: 99%

Quantitative evaluation and chromatographic fingerprinting for the quality assessment of Pudilan tablet

Tang

Zhou

et al. 2023

AChrom

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An easy, quick, and sensitive approach adopting ultra-performance liquid chromatography (UPLC) equipped with diode array detector was used to analyze and systematically evaluate the quality of Pudilan tablets manufactured by 12 distinct pharmaceutical companies. In this research, 15 peaks were chosen as the common peaks to assess the similarities for different batches (S1–S43) of Pudilan tablet samples. In comparison with the control fingerprint, similarity values for 43 batches of samples exceeded 0.922. In addition, by analyzing the reference substances of epigoitrin, caffeic acid, chlorogenic acid, acetylcorynoline, baicalin and baicanshialein, the chromatogram of the 6 reference substances was established. The recoveries for the reference substances which demonstrated good regression in the linear range (r 2 > 0.999) were in the range of 98.3–101.1%. The results demonstrated that the established method was highly accurate, efficient and reliable. This study provides a valid, dependable and pragmatic method to evaluate the quality of Pudilan tablet.

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