Abstract
Saxagliptin is a new oral hypoglycaemic (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs and is approved the registration of 5 mg Onglyza tablet by FDA Center for Drug Evaluation and Research (CDER) in May 2011. A novel Stability indicating HPLC assay method has been established for determination of Saxagliptin in the standard drug Saxagliptin and in the dosage forms using reverse phase Kromasil C18, 150 X 4.6 mm, 5μm column, in the mobile phase phosphate buffer (pH 4.5) and methanol (65:35) at flow rate 1mLmin-1 with UV detection at 230 nm. The retention time was found to be 5.12 min. The proposed method was found to be linear at concentration of 1 to 10 μgmL-1 (R2=0.9899). The limit of detection and limit of quantification was 0.10 μgmL-1 and 0.28 μgmL-1 respectively and the method was found to be specific. Relative Standard deviation for precision of the method in inter-day and intra-day was found to be in range 0.22 – 0.71 and 0.28 – 0.76 % respectively. The percentage recovery ranges from 99.90 – 101.03%. The specificity of the method was ascertained by force degradation studies and the degraded products were well resolved from the analyte peak with significant difference in their RT values. Also, the method developed, in the presence of drug impurities, were satisfactorily applied to the analysis of the pharmaceutical formulations and proved to be specific and accurate for the quality control of Saxagliptin in pharmaceutical dosage forms.
