Development and validation of aranosa assay in the dosage form
https://doi.org/10.17650/1726-9784-2018-17-2-57-62
Abstract
Background. Aranosa, a drug of nitrosoalkylureas class, was developed and studied at N.N. Blokhin NMRCO, Russia, and at present it is produced by N.N. Blokhin NMRСO branch “Naukoprofi”. One of the stages of the drug standardization is the development of an assay technique for quantitative determination of active substance in the final drug dosage form.
Objective. Development and validation of an assay for quantitative determination of Aranosa in the dosage form.
Materials and methods. The study used “Aranosa, lyophilisate for solution for injection 0.5 g”; Аranosa, substance-powder (N.N. Blokhin NMRCO branch “Naukoprofi”); polyvinylpyrrolidone low-molecular medical; sorbic acid. Method: spectrophotometry.
Results. An assay was developed for quantitative spectrophotometric determination of Aranosa in the dosage form “Aranosa, lyophilisate for solution for injection 0.5 g”. Validation was performed to prove reliability and accuracy of the obtained results. The assay was evaluated by validation characteristics, such as specificity, linearity, trueness, precision.
Conclusions. The developed assay is provided with trueness, repeatability, precision, and linearity and can be used in the range of 80– 120 % of nominal Aranosa content in the dosage form.
About the Authors
Z. S. Shprakh
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
E. V. Ignаteva
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
I. V. Yartseva
N.N. Blokhin National Medical Research Center of Oncology, Ministry of Health of Russia
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
Russian Federation
24 Kashirskoe Shosse, Moscow 115478
References
1. Harkevich G.Yu., Demidov L.V. Modern view on the medicinal treatment of disseminated skin melanoma. Prakticheskaya Omkologiya = Practical oncology 2012;2(13):143–9 (In Russ.)
2. Harkevich G.Yu., Orlova K.V., Timofeev I.V., Demidov L.V. National antitumor drug Aranosa in the treatment of patients with metastatic skin melanoma – the results of a prospective randomized study. Pharmateka = Pharmatec 2017;8:66–70 (In Russ.)
3. Shprakh Z.S., Baryshnikov A.Yu. National antitumor drugs. In: Rational pharmacotherapy in oncology. Eds. M.I. Davydov and V.A. Gorbunova. М.: LitTerra, 2012;95–101 (In Russ.)
4. № 61- ФЗ. On circulation of medicinal products with amendments and changes: Federal Law of the Russian Federation of 12 April 2010 No. 61-FZ (In Russ.) http://government.ru/docs/all/101658.
5. ICH Harmonized Tripartite Guideline. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Q6A). [Electronic resource]. Access mode: http://www.ich.org/products/guidelines/quality/article/quality-guidelines. html.
6. Yartceva I.V., Ignateva E.V., Gatinskaja L.G. et al. Validation of the method for quantitative determination of Aranose in a substance. Materials of the All-Russian Scientific and Practical Conference with International Participation “Domestic Antitumor Preparations”, Moscow, 2008. P. 56 (In Russ.)
7. State Pharmacopoeia of the Russian Federation. XIII edn. Vol. 1. Moscow, 2015. (In Russ.)
8. ICH Harmonized Tripartite Guideline. Validation of analytical procedures: text and methodology. Q2 (R1) [Electronic resource]. Electronical data. Genava cop. 2005. – Access mode: http://www.ich.org/products/guidelines/quality/article/quality-guide-lines.html.
9. Ermer J., Miller J.H. McB. Validation of methods in pharmaceutical analysis: examples of best practices. Moscow: VIALEK, 2013. 495 p. (In Russ.)
10. Shprakh Z.S., Ignateva E.V., Yartceva I.V. Validation of the method of quantitative determination of Aranose in a dosage form. Materials of the All-Russian Scientific and Practical Conference with International Participation “National Antitumor Drugs”. Moscow, 2018. P. 85 (In Russ.)
Review
For citations:
Shprakh Z.S., Ignаteva E.V., Yartseva I.V. Development and validation of aranosa assay in the dosage form. Russian Journal of Biotherapy. 2018;17(2):57-62. (In Russ.) https://doi.org/10.17650/1726-9784-2018-17-2-57-62
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