Development and validation of a stability-indicating high performance liquid chromatographic assay for determination of cariprazine in bulk form and in drug product

被引：5
作者：
Toujani, E. [1 ,2 ]
Mejri, W. [1 ]
Lassoued, H. E. [2 ]
Toujani, S. [3 ]
Fliss, O. [1 ]
Cheikh, M. H. B. [2 ]
Safta, F. [2 ]
机构：
[1] Natl Control Lab Tunisia, Jebel Lakhdar St, Bab Saadoun Tunis 1006, Tunisia
[2] Univ Monastir, Fac Pharm Monastir, Lab Chem Galen & Pharmacol Dev Med LR12ES09, Ibn Sina St, Monastir 5000, Tunisia
[3] Fac Med Tunis, Djebel Lakhdhar St, Bab Saadoun Tunis 1007, Tunisia
来源：
ANNALES PHARMACEUTIQUES FRANCAISES | 2023年 / 81卷 / 01期
关键词：
Cariprazine; Stability; HPLC; LC-MS; MS; Characterization; RECEPTOR PARTIAL AGONIST; RAPID-DETERMINATION; FORCED DEGRADATION; DOPAMINE D-3; BIPOLAR; RGH-188; SCHIZOPHRENIA; METABOLITES; DISORDER; PLASMA;
D O I：
10.1016/j.pharma.2022.08.007
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The aim of the present study is to develop a stability indicating high performance liquid chromatographic method for the determination of cariprazine in bulk substance and in drug product. The chromatographic separation was carried out using a Phenomenex Kinetex & REG; C18 column (5 & mu;m, 250 x 4.6 mm) and a mobile phase consisting of acetonitrile-potassium dihy-drogen orthophosphate buffer (pH 4; 50 mM) (30:70, v/v), at a flow rate of 1 ml min-1 and UV detection at 248 nm. The column was maintained at 25 degrees C and an injection volume of 20 & mu;L was used. Stress testing of cariprazine bulk substance and drug product was performed according to the International Conference on Harmonization (ICH) Q1A (R2) guideline. Various stress con-ditions were tested including acidic, alkaline and neutral hydrolysis, humidity, oxidation, dry heat and photolysis. A total of three degradation products (DPs) were formed. Among them two DPs were successfully characterized with the liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. & COPY; 2022 Acad & PRIME;emie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.
引用
收藏
页码：83 / 93
页数：11
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