Validation of a Quantitative Determination Method for Ormustine in a Lyophilized Dosage Form


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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.

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


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