Validation of the quantitative determination of risperidone and paliperidan by HPLC
EDN: ULGLQJ
Abstract
Objective - validation of the developed method by HPLC for the quantitative determination of risperidone and paliperidone for the purposes of chemical-toxicological studies and drug therapeutic monitoring.
Material and methods. The objects of the study were standard samples of risperidone and paliperidone, model mixtures for the preparation of model and blank solutions.
Results. During the validation process, the specificity and separation ability of the method for the determination of risperidone and paliperidone were evaluated. The metrological characteristics were evaluated for the following validation parameters: linearity, correctness, and precision. The correlation coefficient was more than 0.99, and the openability is in the specified range. The calculated data meets of parameter convergence correspond to the specified criteria.The limit of quantification for both substances was 1 µg/ml.
Сonclusion. The validation of the method for the quantitative determination of risperidone and paliperidone with their combined presence in model mixtures, as well as individually for the purposes of chemical and toxicological analysis and drug monitoring for a number of parameters was carried out.
About the Authors
Ruslan M. Bulatov
Perm State Pharmaceutical Academy (PSPA)
Russian Federation
Russian Federation
Post-graduate student of the Department of Toxicological Chemistry, PSPA, Perm, Russian Federation
Tamara L. Malkova
Perm State Pharmaceutical Academy (PSPA)
Russian Federation
Russian Federation
Denis R. Sabirzyanov
Perm State Pharmaceutical Academy (PSPA)
Russian Federation
Russian Federation
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Review
For citations:
Bulatov R.M., Malkova T.L., Sabirzyanov D.R. Validation of the quantitative determination of risperidone and paliperidan by HPLC. Humans and their health. 2025;28(4):131-137. (In Russ.) EDN: ULGLQJ
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