Application of total error concept in the analytical method validation for the assay of essential amino acids by precolumn derivatization

Simple item page
dc.contributor.authorAasodi, Ramachandra Reddyen_US
dc.contributor.authorMurugan, Ven_US
dc.contributor.authorPremakumari, KBen_US
dc.date.accessioned2020-10-16T08:56:55Z
dc.date.available2020-10-16T08:56:55Z
dc.date.issued2020-05
dc.description.abstractA pre-Ultraperformance Liquid Chromatography (UPLC) column derivatization procedure was developed for thesimultaneous quantification of essential amino acids (EAAs) in the solid oral dosage pharmaceutical formulation.This analytical procedure has been validated with the help of the concept of total error. The total error approach (thecombination of systematic and random error) is a decision-making tool for ensuring the performance of the method.Fluorenylmethyloxycarbonyl chloride was used as a derivatization reagent. The amino acid derivatives were separatedon a C18 column (internal diameter 2.1 × 100 mm, 1.6 µm) by gradient elution with 0.1% trifluoroacetic acid andacetonitrile:water (90:10, v/v), respectively, as mobile phase A and B. About 10 EAAs could be detected at 265 nm in35 minutes with a flow rate of 0.25 ml/min. The linearity range of each amino acid was between 0.1 and 1.0 mg/ml.The accuracy and risk profiles were considered acceptable across the range. The precolumn derivatization procedureand the concept of the validation of total error could be used as an appropriate strategy to demonstrate the suitabilityof the analytical procedure for the separation and evaluation of EAA in solid oral dosage formulations.en_US
dc.identifier.affiliationsCollege of Pharmaceutical Sciences, Dayananda Sagar University, Bengaluru, India.en_US
dc.identifier.citationAasodi Ramachandra Reddy, Murugan V, Premakumari KB. Application of total error concept in the analytical method validation for the assay of essential amino acids by precolumn derivatization. Journal of Applied Pharmaceutical Science. 2020 May; 2020 May: 031-042en_US
dc.identifier.issn2231-3354
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/210746
dc.languageenen_US
dc.publisherOpen Science Publishers LLPen_US
dc.relation.issuenumber5en_US
dc.relation.volume10en_US
dc.source.urihttps://dx.doi.org//10.7324/JAPS.2020.10505en_US
dc.subjectEssential amino acidsen_US
dc.subjectpre-column derivatizationen_US
dc.subjecttotal erroren_US
dc.subjectUPLCen_US
dc.subjectaccuracy profile.en_US
dc.titleApplication of total error concept in the analytical method validation for the assay of essential amino acids by precolumn derivatizationen_US
dc.typeJournal Articleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
japs2020v10n5p031.pdf
Size:
3.03 MB
Format:
Adobe Portable Document Format
Download
Collections
Journal of Applied Pharmaceutical Science (JAPS)