scholarly journals Isolation, Identification and Characterization of Degradation Impurity of Atorvastatin in Fixed Dose Combination of Atorvastatin and Ezetimibe

2019 ◽  
Vol 11 (05) ◽  
Author(s):  
Rajesh Desai ◽  
Suresh Koradia
Keyword(s):  
Reversed Phase ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Forced Degradation ◽  
Preparative Hplc ◽  
Atorvastatin Calcium ◽  
Isolation And Characterization ◽  
Dose Combination ◽  
Liquid Chromatographic

The objective of this study is to isolation and characterization of unknown degradation product of Atorvastatin calcium in combination formulation product with Ezetimibe by using modern techniques of separation and aracterization. An unknown impurity is generating during a forced degradation study of Atorvastatin and Ezetimibe fixed-dose combination tablets. By using the gradient reversed-phase high-pressure liquid chromatographic method, unknown degradation impurity was detected and quantified in the range of 0.05% to 0.2% of Atorvastatin. The impurity was enriched by extreme oxidation degradation of Atorvastatin and isolated through preparative HPLC. The structure of the impurity was characterized by mass and NMR spectrum.

scholarly journals Drug–Drug Compatibility Evaluation of Sulfasalazine and Folic Acid for Fixed-Dose Combination Development Using Various Analytical Tools

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 400
Author(s):  
Mario-Livio Jeličić ◽  
Edvin Brusač ◽  
Stanislav Kurajica ◽  
Matija Cvetnić ◽  
Daniela Amidžić Amidžić Klarić ◽  
...  
Keyword(s):  
Folic Acid ◽  
Principal Component ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Forced Degradation ◽  
Chemical Compatibility ◽  
Dose Combination ◽  
Multiple Drugs ◽  
Analytical Tools ◽  
Insight Into

The simultaneous administration of sulfasalazine and folic acid is regular practice in the therapy of inflammatory bowel diseases in order to maintain sufficient folate concentration in patients. Having multiple drugs in the therapy increases the possibility of patients failing adherence, thus unintentionally endangering their health. A fixed-dose combination of sulfasalazine and folic would simplify the classical polytherapeutic approach; however, the physicochemical compatibility investigation of two active pharmaceutical ingredients plays an important role in the development of such a product. In this work, various analytical tools were used to determine the physicochemical compatibility of sulfasalazine and folic acid. For the evaluation of chemical compatibility, infrared spectroscopy in combination with advanced statistical methods, such as the principal component analysis and cluster analysis, were used, whilst a simultaneous thermogravimetry/differential thermal analysis gave us an insight into the physical compatibility of two drugs. Isothermal stress testing, forced degradation and dissolution studies, followed by the analysis with a developed chromatographic method for the monitoring of folic acid, sulfasalazine and two of its related impurities, sulfapyridine and salicylic acid, gave us an insight into its chemical compatibility. The combination of the results obtained from the used techniques implies a satisfactory physicochemical compatibility between sulfasalazine and folic acid, which opens the path to the development of the proposed fixed-dose combination.

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