Estimation of measurement uncertainty and validation of RP-HPLC for simultaneous determination of five antihistamines in pharmaceutical formulations

Jebali, Sami; Bahri, Sonia; Latrous, Latifa

doi:10.1007/s00769-019-01422-7

Cited by 8 publications

(2 citation statements)

References 32 publications

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“…The measurement and assessment uncertainty based on method validation and calibration conditions were estimated according to the procedures recommended by EURACHEM/CITAC Guide CG4/NABL 141 and protocol. , The exercise includes (i) defining measurement criteria, (ii) identifying the sources of uncertainty, (iii) measuring the uncertainties, and (iv) calculating combined and expanded uncertainty …”

Section: Methodsmentioning

confidence: 99%

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Quantitative Determination and Characterization of a Kashmir Saffron (Crocus sativus L.)-Based Botanical Supplement Using Single-Laboratory Validation Study by HPLC-PDA with LC–MS/MS and HPTLC Investigations

et al. 2021

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Food ingredients hold a higher nutritional value as a botanical supplement playing a vital role in modifying and maintaining the physiological conditions that improve human health benefits. The Kashmir saffron ( Crocus sativus L; KCS) obtained from dried stigmas is known for its aroma precursors and apocarotenoid derivatives, imparting a wide range of medicinal values and therapeutic benefits. In the present study, a simultaneous determination of apocarotenoids and flavonoids in stigma-based botanical supplements was carried out using analytical investigations. The high-performance thin-layer chromatography-based qualitative analysis of the raw material (stigmas, stamens, and tepals) and stigma extract has been carried out to identify apocarotenoids and flavonoids. The rapid HPLC-PDA method for the simultaneous quantification of KCS apocarotenoids was robust, precise (<5.0%), linear ( R 2 > 0.99), and accurate (80–110%) as per the single-laboratory validation data. Furthermore, the combined-expanded uncertainty (95%; K = 2) was calculated and found as 0.0035–0.007% (<5.0%) as per the EURACHEM guide for this HPLC analysis. Additionally, an untargeted identification of 36 compounds in the botanical supplement was based on the elution order, UV–vis spectra, mass fragmentation pattern, and standards by ESI-MS/MS analysis with comprehensive chromatographic fingerprinting. Thus, these analytical approaches enable a composite profile of the stigma-based extract as a potential supplement for human health benefits.

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Section: Methodsmentioning

confidence: 99%

“…47,48 The exercise includes (i) defining measurement criteria, (ii) identifying the sources of uncertainty, (iii) measuring the uncertainties, and (iv) calculating combined and expanded uncertainty. 49 4.10. Assessment of Uncertainty.…”

Section: Methodsmentioning

confidence: 99%