Parameters of validation of an HPLC assay method ; Parametrii de validare a unei metode HPLC de dozare
| العنوان: | Parameters of validation of an HPLC assay method ; Parametrii de validare a unei metode HPLC de dozare |
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| المؤلفون: | Donici, Elena, Turlă, Daniela |
| بيانات النشر: | Instituţia Publică Universitatea de Stat de Medicină şi Farmacie „Nicolae Testemiţanu” din Republica Moldova |
| سنة النشر: | 2022 |
| المجموعة: | Institutional Repository in Medical Sciences of Nicolae Testemitanu State University of Medicine and Pharmacy |
| مصطلحات موضوعية: | HPLC, parameters of validation |
| الوصف: | 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. ; Study conducted with the support of the project 20.80009.8007.14 “Complex researches for the elaboration of new local anti-infectious pharmaceutical products for the optimization of pharmacotherapy of dental, oropharyngeal and auricular diseases”, within the State Program (2020-2023), project leader: Valica Vladimir, PhD, univ, prof., contracting authority: National Agency for Research and Development. ; Introducere. HPLC este o metodă fizico-chimică care poate detecta, separa și cuantifica substanțele medicamentoase. Conform USP ediția a 28-a, ... |
| نوع الوثيقة: | other/unknown material |
| وصف الملف: | application/pdf |
| اللغة: | unknown |
| تدمد: | 2345-1467 |
| Relation: | Revista de Științe ale Sănătății din Moldova = Moldovan Journal of Health Sciences: Conferinţa ştiinţifică anuală "Cercetarea în biomedicină și sănătate: calitate, excelență și performanță", 2022; DONICI, Elena, TURLĂ, Daniela. Parameters of validation of an HPLC assay method = Parametrii de validare a unei metode HPLC de dozare. In: Revista de Științe ale Sănătății din Moldova = Moldovan Journal of Health Sciences. 2022, vol. 29(3), anexa 1, p. 485. ISSN 2345-1467.; https://conferinta.usmf.md/wp-content/uploads/MJHS_29_3_2022_anexa.pdf; http://repository.usmf.md/handle/20.500.12710/23292 |
| الاتاحة: | http://repository.usmf.md/handle/20.500.12710/23292 https://hdl.handle.net/20.500.12710/23292 https://conferinta.usmf.md/wp-content/uploads/MJHS_29_3_2022_anexa.pdf |
| رقم الانضمام: | edsbas.9D0F6335 |
| قاعدة البيانات: | BASE |
| تدمد: | 23451467 |
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