Κατεύθυνση Φαρμακευτική Ανάλυση - Έλεγχος ποιότητας
Library of the School of Science

2020-03-08

2020

Karkaletsi Athanasia

Παντερή Ειρήνη, Καθηγήτρια, Τμήμα Φαρμακευτικής, Εθνικό και Καποδιστριακό Πανεπιστήμιο Αθηνών

Έλεγχος ποιότητας του ακετυλοσαλικυλικού οξέος, της ατορβαστατίνης και της ραμιπρίλης σε κάψουλες καθορισμένης δόσης συνδυασμού: Ανάπτυξη και επιβεβαίωση μεθόδου υγροχρωματογραφίας υδρόφιλης αλληλεπίδρασης με ανιχνευτή συστοιχίας φωτοδιόδων (HILIC-PDA) για τον ποσοστικό προσδιορισμό των δραστικών ουσιών.

Greek

Quality control of acetylsalicylic acid, atorvastatin and ramipril in fixed-dose combination capsules. Development and confirmation of a hydrophilic interaction liquid chromatography (HILIC) method coupled with PDA detector for the quantification of active pharmaceutical ingredients.

Cardiovascular disease is one of the first causes of death worldwide and is usually accompanied by another established disease such as diabetes. Cardiovascular disease is a group of disorders of the heart and blood vessels that often cause heart attacks and strokes. In recent years, fixed-dose pharmaceutical preparations containing two or more active pharmaceutical ingredients have been developed and used. These preparations are an attractive option for the physicians and result in faster and more effective control of the cardiovascular disease. The first preparations in this category approved for commercial use in the European Union contain acetylsalicylic acid, atorvastatin and ramipril.
In the present study a hydrophilic interaction liquid chromatographic method coupled with a photodiode array detector was developed and evaluated for the simultaneous determination of acetylsalicylic acid, atorvastatin and ramipril in capsules. HILIC is a relatively new technique of great interest which is an ideal choice for the analysis of compounds with diverse physicochemical properties, using hydrophilic static phases, while the mobile phase is a mixture of water and organic solvent. During the method development the chromatographic conditions were optimized to achieve adequate retention and separation of the APIs. The method was evaluated for the main quality characteristics (Linearity, Accuracy, Precision, Limit of Detection, Limit of Quantitation, Stability Studies) and applied to the analysis of fixed-dose pharmaceutical preparations. The method is applicable for routine analysis and content uniformity test of acetylsalicylic acid, atorvastatin and ramipril in fixed-dose combination capsules.

Science

Acetylsalicylic acid, atorvastatin, ramipril, HILIC, capsules

Yes

3

Yes

102

109

File access is restricted only to the intranet of UoA.

https://pergamos.lib.uoa.gr/uoa/dl/object/2898899