ICH guidelines – “Q” series (quality guidelines) - A review

Bhavyasri, Khagga; Vishnumurthy, Kaitha Manisha; Rambabu, D; Sumakanth, Mogili

doi:10.30574/gscbps.2019.6.3.0034

Cited by 22 publications

(5 citation statements)

References 4 publications

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“…To guarantee that the recommended analytical approach was appropriate and valid for the highly accurate and precise detection of the drug under investigation, method validation was carried out according to recommended “International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use” (ICH) guidelines [ 56 ], the established FL systems for the determination of OMZ and DOM were validated.…”

Section: Resultsmentioning

confidence: 99%

Plant extract mediated synthesis of ZnO and CeO2 nanoparticles for spectrofluorometric assay of omeprazole and domperidone in pharmaceuticals

Alarfaj,

Alshehri,

Al-Tamimi

et al. 2024

Heliyon

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Section: Resultsmentioning

confidence: 99%

Plant extract mediated synthesis of ZnO and CeO2 nanoparticles for spectrofluorometric assay of omeprazole and domperidone in pharmaceuticals

Alarfaj,

Alshehri,

Al-Tamimi

et al. 2024

Heliyon

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“…The chromatographic method developed for simultaneous analysis was validated for specificity, linearity (from the calibration curve), precision, accuracy, the recovery of the analytes and the stability of the solution according to guidelines of the International Conference on Harmonisation (ICH) [ 46 , 47 ]. The specificity was examined by comparing the retention times and analyzing the absorption spectra of the chromatograms obtained for the samples and the standard solution in the range from 190 to 440 nm.…”

Section: Discussionmentioning

confidence: 99%

HPLC-PDA Method for Quantification of Bioactive Compounds in Crude Extract and Fractions of Aucklandia costus Falc. and Cytotoxicity Studies against Cancer Cells

et al. 2023

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Aucklandia costus Falc. (Synonym: Saussurea costus (Falc.) Lipsch.) is a perennial herb of the family Asteraceae. The dried rhizome is an essential herb in the traditional systems of medicine in India, China and Tibet. The important pharmacological activities reported for Aucklandia costus are anticancer, hepatoprotective, antiulcer, antimicrobial, antiparasitic, antioxidant, anti-inflammatory and anti-fatigue activities. The objective of this study was the isolation and quantification of four marker compounds in the crude extract and different fractions of A. costus and the evaluation of the anticancer activity of the crude extract and its different fractions. The four marker compounds isolated from A. costus include dehydrocostus lactone, costunolide, syringin and 5-hydroxymethyl-2-furaldehyde. These four compounds were used as standard compounds for quantification. The chromatographic data showed good resolution and excellent linearity (r2 ˃ 0.993). The validation parameters, such as inter- and intraday precision (RSD < 1.96%) and analyte recovery (97.52–110.20%; RSD < 2.00%),revealed the high sensitivity and reliability of the developed HPLC method. The compounds dehydrocostus lactone and costunolide were concentrated in the hexane fraction (222.08 and 65.07 µg/mg, respectively) and chloroform fraction (99.02 and 30.21 µg/mg, respectively), while the n-butanol fraction is a rich source of syringin (37.91 µg/mg) and 5-hydroxymethyl-2-furaldehyde (7.94 µg/mg). Further, the SRB assay was performed for the evaluation of anticancer activity using lung, colon, breast and prostate cancer cell lines. The hexane and chloroform fractions show excellent IC50 values of 3.37 ± 0.14 and 7.527 ± 0.18 µg/mL, respectively, against the prostate cancer cell line (PC-3).

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“…Figure 1B shows the worst situation, in which α-ketoglutaric acid has high concentration and coelutes with acetic acid. The matrix effect was ruled out by the negligible difference (p > 0.05) observed between the external and internal calibration slope [27].…”

Section: Methods Validationmentioning

confidence: 99%

Fast, Direct Dihydrouracil Quantitation in Human Saliva: Method Development, Validation, and Application

Campanella

Lomonaco

Benedetti

et al. 2022

IJERPH

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Background. Salivary metabolomics is garnering increasing attention in the health field because of easy, minimally invasive saliva sampling. Dihydrouracil (DHU) is a metabolite of pyrimidine metabolism present in urine, plasma, and saliva and of fluoropyrimidines-based chemotherapeutics. Its fast quantification would help in the identification of patients with higher risk of fluoropyrimidine-induced toxicity and inborn errors of pyrimidine metabolism. Few studies consider DHU as the main salivary metabolite, but reports of its concentration levels in saliva are scarce. We propose the direct determination of DHU in saliva by reversed-phase high-performance liquid chromatography (RP-HPLC-UV detector) as a simple, rapid procedure for non-invasive screening. Methods. The method used was validated and applied to 176 saliva samples collected from 21 nominally healthy volunteers and 4 saliva samples from metastatic colorectal cancer patients before and after receiving 5-fluorouracil chemotherapy. Results. DHU levels in all samples analyzed were in the μmol L−1 range or below proving that DHU is not the main metabolite in saliva and confirming the results found in the literature with LC-MS/MS instrumentation. Any increase of DHU due to metabolism dysfunctions can be suggestive of disease and easily monitored in saliva using common, low-cost instrumentation available also for population screening.

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ICH guidelines – “Q” series (quality guidelines) - A review

Cited by 22 publications

References 4 publications

Plant extract mediated synthesis of ZnO and CeO2 nanoparticles for spectrofluorometric assay of omeprazole and domperidone in pharmaceuticals

Plant extract mediated synthesis of ZnO and CeO2 nanoparticles for spectrofluorometric assay of omeprazole and domperidone in pharmaceuticals

HPLC-PDA Method for Quantification of Bioactive Compounds in Crude Extract and Fractions of Aucklandia costus Falc. and Cytotoxicity Studies against Cancer Cells

Fast, Direct Dihydrouracil Quantitation in Human Saliva: Method Development, Validation, and Application

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