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• W4316498834 abstract "This work presented the integration of the Analytical Quality by Design concept in developing a UPLC method for the quantification of saponins and phenolic acids in two Compound Danshen Dripping Pills intermediates of a concentrated extract and a supernatant. Prior knowledge and systematic risk analysis were conducted to identify potential critical method parameters (CMPs) that affected critical quality attributes (CQAs). A definitive screening design was employed to investigate the quantitative relationship among the intermediate type, CPPs, and CQAs. Intermediate type was added in the experimental design table as a categorical variable. After the models were built, the method operable design region (MODR) was calculated with an exhaustive search-Monte Carlo method. The CPP combinations with a 95 % or higher probability of reaching the preset standard were collected in MODR. The MODR robustness test was conducted with a Plackett–Burman design. The separation of analytes was achieved with a Waters Acquity HSS T3 (100 × 2.1 mm, 1.8 µm) column at 30 °C, using 0.05 % phosphoric acid and acetonitrile as the mobile phases in gradient elution at a flow rate of 0.40 mL/min. The elution was monitored at UV detection wavelengths of 280 nm and 203 nm. The optimized method was also validated. Good robustness, accuracy, precision, stability and repeatability, and linear regression (R > 0.9997) were obtained. All recoveries of the 9 compounds ranged from 97.8 % to 101.7 %, with an RSD of less than 3.49 %. Nine batches of Danshensu, protocatechualdehyde, rosmarinic acid, salvianolic acid B, salvianolic acid A, notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, and ginsenoside Rb1 were analysed. Danshensu was found to be the compound with the highest content." @default.
• W4316498834 created "2023-01-16" @default.
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• W4316498834 date "2023-04-01" @default.
• W4316498834 modified "2023-10-16" @default.
• W4316498834 title "Analytical quality by design oriented development of the UPLC method for analysing multiple pharmaceutical process intermediates: A case study of Compound Danshen Dripping Pills" @default.
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• W4316498834 doi "https://doi.org/10.1016/j.microc.2023.108438" @default.
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