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Ultima descărcare din IBN: 2024-02-27 20:41 |
SM ISO690:2012 DONICI, Elena, TURLĂ, Daniela. Parameters of validation of an HPLC assay method. In: Revista de Ştiinţe ale Sănătăţii din Moldova, 2022, nr. 3 An.1(29), p. 485. ISSN 2345-1467. |
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Revista de Ştiinţe ale Sănătăţii din Moldova | ||||||
Numărul 3 An.1(29) / 2022 / ISSN 2345-1467 | ||||||
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Pag. 485-485 | ||||||
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Background. HPLC is a physico-chemical method, which is able to detect, separate, and quantify the drug substances. According to USP 28th edition, the validation of an analytical method is a process that establishes through laboratory studies the necessary conditions to be applied analytically. Objective of the study. Evaluation of the parameters of validation of an HPLC method of assay of drug substances. Material and Methods. Electronic databases: While, Scopus and Springer. The information was searched by using: „HPLC”, „validation”, „parameters of validation” and „assay”. Also, the search was conducted by using printed pharmaceutical and chemical journals. 87 bibliographic sources were eligible for the study. Results. HPLC method linearity is usually based on five concentration levels between 70% and 130% of the nominal concentration, each to be injected three times. Specificity is used to provide an exact result that allows an accurate statement of the analyte in a sample. The accuracy expresses the closeness of agreement between the true values. The precision expresses the closeness of agreement between a series of measurements. The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters. Conclusion. On the various international regulatory documents the required validation parameters for an HPLC assay method are linearity, specificity, accuracy, precision, and robustness. |
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Cuvinte-cheie HPLC, parameters of validation, HPLC, parametri de validare |
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