Development and validation of a procedure for assay of a new substance

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DOI: https://doi.org/10.29296/25419218-2019-07-02
Issue: 
7
Year: 
2019

E.S. Mishchenko(1), D.S. Lazaryan(1), A.A. Ozerov(2) 1-Pyatigorsk Medical and Pharmaceutical Institute, Branch, Volgograd State Medical University, 11, Kalinin Pr., Pyatigorsk 357532, Russian Federation; 2-Volgograd State Medical University, 1, Pavshikh Bortsov St., Volgograd 400131, Russia

Introduction. The Volgograd State Medical University synthesized a new substance from the class of acetanilide derivatives of quinazolin-4(3H)-one (Laboratory Code VMA-10-1). The results of a preliminary pharmacological assay showed that this compound is characterized by an original spectrum of psychotropic activity. The substance has weak basic properties and is very slightly soluble in water; it is advisable to use an acid-base titration assay in the non-aqueous media for quantification of the substance. Objective: to develop and validate a procedure for assay of the new substance VMA-10-18. Material and methods. The investigation object was the standard sample of the new substance VMA-10-18. Class A volumetric glassware was used in the investigation. The investigators employed formic acid, acetic acid, and acetic anhydride as solvents, 0.1 M perchloric acid as a titrant, and 0.1% crystal violet solution as an indicator. The procedure was validated in accordance with the requirements of the 14th edition of the State Pharmacopoeia of the Russian Federation. Results. The optimal conditions were established for the titrimetric analysis of the substance derived from quinazolin-4(3H)-one. The analytical procedure was validated in terms of specificity, linearity, analytical area, precision, and accuracy. Conclusion. The developed procedure for assaying the new substance, a quinazolin-4(3H)-one derivative, is valid and can be used in quality control.
Keywords: 
quinazolin-4(3H)-one
VMA-10-18
acid-base titration
formic acid
glacial acetic acid
acetic anhydride
validation
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