Validation of a Quantitative Determination Method for Ormustine in a Lyophilized Dosage Form
- Authors: Bunyatyan N.D.1,2, Nikolaeva L.L.1,3, Olefir Y.V.2, Sanarova E.V.3, Oborotova N.A.1,2, Prokof’ev A.B.1,2, Ignat’eva E.V.3, Yartseva I.V.3, Gulyakin I.D.3
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Affiliations:
- I. M. Sechenov First Moscow State Medical University (Sechenov University)
- Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- N. N. Blokhin Russian Oncological Research Center, Russian Academy of Medical Sciences
- Issue: Vol 51, No 11 (2018)
- Pages: 1037-1040
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244899
- DOI: https://doi.org/10.1007/s11094-018-1735-3
- ID: 244899
Cite item
Abstract
Validation results for a spectrophotometric quantitative determination method for ormustine in a lyophilized dosage form are presented. The method is shown to be suitable for quantitative determination of ormustine with respect to parameters such as specificity, linearity, accuracy, repeatability, and intermediate precision.
Keywords
About the authors
N. D. Bunyatyan
I. M. Sechenov First Moscow State Medical University (Sechenov University); Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Author for correspondence.
Email: ndbun@mail.ru
Russian Federation, Moscow, 119991; Moscow, 127051
L. L. Nikolaeva
I. M. Sechenov First Moscow State Medical University (Sechenov University); N. N. Blokhin Russian Oncological Research Center, Russian Academy of Medical Sciences
Email: ndbun@mail.ru
Russian Federation, Moscow, 119991; Moscow, 115478
Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, Moscow, 127051
E. V. Sanarova
N. N. Blokhin Russian Oncological Research Center, Russian Academy of Medical Sciences
Email: ndbun@mail.ru
Russian Federation, Moscow, 115478
N. A. Oborotova
I. M. Sechenov First Moscow State Medical University (Sechenov University); Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, Moscow, 119991; Moscow, 127051
A. B. Prokof’ev
I. M. Sechenov First Moscow State Medical University (Sechenov University); Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, Moscow, 119991; Moscow, 127051
E. V. Ignat’eva
N. N. Blokhin Russian Oncological Research Center, Russian Academy of Medical Sciences
Email: ndbun@mail.ru
Russian Federation, Moscow, 115478
I. V. Yartseva
N. N. Blokhin Russian Oncological Research Center, Russian Academy of Medical Sciences
Email: ndbun@mail.ru
Russian Federation, Moscow, 115478
I. D. Gulyakin
N. N. Blokhin Russian Oncological Research Center, Russian Academy of Medical Sciences
Email: ndbun@mail.ru
Russian Federation, Moscow, 115478