Original scientific paper

Determination of Simvastatin in Pharmaceutical Dosage Forms by Optimized and Validated Method Using HPLC/UV

Lukasz Guzik ; Department of Inorganic Chemistry, Faculty of Pharmacy, Medical University of Gdansk, Hallera 107 80-416 Gdansk, Poland
Wojciech Mrozik ; Department of Inorganic Chemistry, Faculty of Pharmacy, Medical University of Gdansk, Hallera 107 80-416 Gdansk, Poland
Wojciech Kamysz ; Department of Inorganic Chemistry, Faculty of Pharmacy, Medical University of Gdansk, Hallera 107 80-416 Gdansk, Poland

Abstract

Simvastatin belongs to the group of anticholesterol agents used in the treatment of hypercholesteraemia.
Analytical methods used to determine the concentration of this active pharmaceutical ingredient
(API), in dosage forms in the quality tests, are commonly based on high performance liquid chromatography
(HPLC) and should be fast and reliable. The purpose of this study was to compare and validate two
methods of analysis of simvastatin using HPLC and different eluent mixtures: acetonitrile/water vs. methanol/
water in gradient elution. Several columns were tested at different temperatures. However satisfied
peak shapes and validation parameters were obtained for both methods. The one using methanol as an eluent
was chosen for the determination of simvastatin in dissolution tests, mostly due to lower price of the eluent.

Keywords

simvastatin; HPLC/UV; gradient elution; methanol/water; dissolution tests

Hrčak ID:

62222

URI

https://hrcak.srce.hr/62222

Publication date:

1.12.2010.

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