Dissolution Tests of Loxoprofen Sodium Hydrate Tablets Using Ultra High-speed Liquid Chromatography

Abstract

Ultra high-speed liquid chromatography (ultra high-speed LC) has become an increasingly popular method in analytical research fields. This novel analytical system provides fast and efficient chromatographic separation over a wide range of flow rate and pressure. In this study, we applied an ultra high-speed LC system to the analysis of active ingredients, such as loxoprofen sodium hydrate and some additives in the drug formulation. As part of the ultra high-speed LC system utilized in this study was a LaChrom Ultra system (Hitachi, Tokyo, Japan) equipped with a L-2455U diode array detector and a LaChrom Ultra C18 (particle size, 2 μm) column ; as a result, short time stability tests of drugs were accomplished efficiently. Loxoprofen sodium hydrate is one of the most popular non-steroidal anti-inflammatory drugs (NSAIDs) used in Japan. The use of generic products has been strongly encouraged in order to reduce healthcare costs. The active ingredients, strengths, dosage forms and regimen of generic products are the same as those of the innovator's products. However, there are many generic products of loxoprofen sodium hydrate. The most important factor in selection is information concerning the quality of the product. For oral drug products, dissolution tests should be performed, since they provide important information concerning the bioequivalence of generic products. After dissolution tests of brand-name drugs and generic products, their elution behaviors were evaluated by high-speed analysis. We achieved a fast analysis of loxoprofen within 1.0 min, and compared the elution behavior between, the brand-name drug and generic products.