Validation of an Assay Procedure for Ormustine in a Liposomal Dosage Form
- Authors: Bunyatyan N.D.1,2, Oborotova N.A.1,3, Nikolaeva L.L.1,3, Ignat’eva E.V.3, Yartseva I.V.3, Lantsova A.V.3, Prokof’ev A.B.1,2
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Affiliations:
- M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- N. N. Blokhin National Medical Research Center of Oncology (N. N. Blokhin NMRCO), Ministry of Health of the Russian Federation
- Issue: Vol 52, No 9 (2018)
- Pages: 799-802
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/245474
- DOI: https://doi.org/10.1007/s11094-018-1903-5
- ID: 245474
Cite item
Abstract
A spectrophotometric assay for ormustine active ingredient for a liposomal dosage form with antitumor activity was selected and validated for specificity, linearity, accuracy, precision, and intermediate (intralaboratory) precision in order to ensure accurate and precise results. The obtained statistical characteristics were shown to satisfy acceptance criteria for the validation parameters given in domestic regulatory documentation. Ormustine was determined at 396 ± 2 nm because excipients in the dosage form did not absorb in this spectral region. The correlation coefficient for the linearity was >0.997. The relative error of the mean result was <1% for the accuracy. The confidence interval included 100%. The coefficient of variation for the precision and intermediate precision determinations was <1%. The studied method could be used in the range 80 – 120% of the nominal ormustine content in the liposomal dosage form.
Keywords
About the authors
N. D. Bunyatyan
M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia; Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Author for correspondence.
Email: ndbun@mail.ru
Russian Federation, 8/2 Trubetskaya St., Moscow, 119991; 8/2 Petrovskii Blvd., Moscow, 127051
N. A. Oborotova
M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia; N. N. Blokhin National Medical Research Center of Oncology (N. N. Blokhin NMRCO), Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, 8/2 Trubetskaya St., Moscow, 119991; 24 Kashirskoe Shosse, Moscow, 115478
L. L. Nikolaeva
M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia; N. N. Blokhin National Medical Research Center of Oncology (N. N. Blokhin NMRCO), Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, 8/2 Trubetskaya St., Moscow, 119991; 24 Kashirskoe Shosse, Moscow, 115478
E. V. Ignat’eva
N. N. Blokhin National Medical Research Center of Oncology (N. N. Blokhin NMRCO), Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, 24 Kashirskoe Shosse, Moscow, 115478
I. V. Yartseva
N. N. Blokhin National Medical Research Center of Oncology (N. N. Blokhin NMRCO), Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, 24 Kashirskoe Shosse, Moscow, 115478
A. V. Lantsova
N. N. Blokhin National Medical Research Center of Oncology (N. N. Blokhin NMRCO), Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, 24 Kashirskoe Shosse, Moscow, 115478
A. B. Prokof’ev
M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia; Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: ndbun@mail.ru
Russian Federation, 8/2 Trubetskaya St., Moscow, 119991; 8/2 Petrovskii Blvd., Moscow, 127051