Analytical Method Development of Saxagliptin HCl by RP-HPLC
Reversed-phase chromatography is the mainly used in chromatographic mode, it is used to separate neutral molecules in solution based on their hydrophobicity. This technique is the reverse of normal-phase chromatography in the intelligence that it involves the employ of a polar mobile phase and a non-polar stationary phase. A sensitive, accurate, rapid, cost effective and robust HPLC method was developed for the quantification of Saxagliptin Hydrochloride (SGH) with UV detector. In this method, a reversed-phase Grace C18 (250mm x 4.6ID, Particle size: 5 micron) column with a mobile phase of methanol: water (80:20; v/v) at 0.8ml/min flow rate was used to separate SGH with a detection of 212nm.The volume injected was 20 µL. The retention time of SGH was obtained as 4.196 min. Hence it can be applied for routine analysis of Saxagliptin Hydrochloride (SGH) in bulk drug.
Keywords: Saxagliptin Hydrochloride (SGH), RP-HPLC, Assay, Method validation.
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