A capillary electrophoresis method for the determination of soluble monosaccharides in <i>Ginkgo biloba</i> leaves

Liu, Shuo; Li, Xin; Yang, Xiaoxia; Zhou, Linhui; Liang, Xia; Ru-chen, Qiu; Fei, Yun

doi:10.1002/jssc.202100749

Cited by 5 publications

(2 citation statements)

References 30 publications

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“…QbD also designs a quality product that consistently delivers the intended performance. Similar principles and concepts have been adopted for analytical method development, termed ‘analytical QbD’ (Konduru et al, 2022; Kowtharapu et al, 2022; Liu et al, 2022; Subramanian et al, 2020).…”

Section: Methodsmentioning

confidence: 99%

Development and validation of novel RP‐HPLC method for midostaurin determination using analytical quality by design approach from regulatory perspective and determination of major degradation compounds of midostaurin using LC–MS

Reddy

Konduru²,

Gundla

et al. 2022

Biomedical Chromatography

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Midostaurin (MTN), designated as an orphan medicinal product, is emerging as an important drug for treating acute myeloid leukemia and advanced systematic mastocytosis. The proposed method was developed and validated to evaluate the related impurities of MTN. The impurities were separated using a YMC Trait C18 ExRS column (150 Â 4.6 mm, 3 μm). Mobile phase A consisted of a 10-mM concentration of phosphate buffer adjusted to pH 3.0 with diluted orthophosphoric acid, and mobile phase B consisted of 90% acetonitrile and 10% water. The optimized chromatographic conditions were as follows: flow rate, 0.5 mL min À1 ; injection volume, 10 μL;UV detection, 290 nm; and linear gradient program, up to 65 min. The method was developed using an analytical quality by design approach. A systematic flow chart shows the evaluation, control, and life cycle management method. As part of method evaluation, risk assessment was conducted. The method has been validated per current guidelines of the International Conference on Harmonization. The recovery study and linearity ranges were established from the limit of quantification to 150% optimal concentrations. The recovery was found to be between 95.5 and 102.5%, and linearity (r 2 ) was 0.9998-0.9999 for all the identified impurities. The method precision results were achieved below 10% of relative standard deviation. Forced degradation studies were performed under chemical and physical stress conditions. The compound was sensitive to chemical stress conditions. During the study, the analyte degraded and was converted into the identified degradation impurities, and its molecular mass was found using the LC-MS technique.

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Section: Methodsmentioning

confidence: 99%

Development and validation of novel RP‐HPLC method for midostaurin determination using analytical quality by design approach from regulatory perspective and determination of major degradation compounds of midostaurin using LC–MS

Reddy

Konduru²,

Gundla

et al. 2022

Biomedical Chromatography

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show abstract

“…CE is a cost-effective technique that offers excellent resolution and sensitivity, making it an attractive analytical platform for complex food matrices. In the past couple of years, CE-based techniques have been widely applied for the analysis and monitoring of nutritional ingredients in a variety of food products, e.g., amino acids in beers, flavonoids in citrus fruits, monosaccharides in ginkgo bilobas, and starch in rice . They have also been used to determine essential components in milk, such as lactose, lactulose, unsaturated fatty acids, and protein compositions, demonstrating their potential as a routine analytical tool for the dairy industry. − …”

Section: Applicationsmentioning

confidence: 99%