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

页码：83 / 93

页数：11

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