Abstract
Metformin is recommended as a first-line agent for monotherapy and combination therapy for patients with type 2 diabetes mellitus (T2DM). Patients whose glycaemic control deteriorates over time with metformin monotherapy will require additional anti-diabetic medication. The development of HPLC method for simultaneous estimation of anti-diabetic drugs in combination from solid dosage form by HPLC method. To validate the developed HPLC method as per ICH guidelines. The System suitability test ,Capacity factor, Tailing factor, Resolution, Selectivity, Separation factor, Theoretical plates, Regression coefficient, STD for intercept, LOD (limit of detection), LOQ (limit of quantification, Repeatability, Precision studies (Intra-day and Interday/Intermediate), Linearity/Calibration studies, Robustness, Force degradation/Stability indicating studies, Specificity, Drug recovery/accuracy studies are performed. The system suitability test performed for saxagliptin and metformin hydrochloride has achieved all guideline criteria; including tailing factor (T), separation factors (α), theoretical plates (N), capacity factor (k’), resolution (R) and RSD (%), force degradation studies were also performed for both these drugs. So combinedly we concluded that the proposed reverse phase chromatographic (RP-HPLC) analytical method for the simultaneous estimation in both bulk and tablet formulation have complied the ICH and US-FDA guidelines.
Highlights
According to statements by the American Diabetes Association/European Association for the Study of Diabetes and the American Association of Clinical Endocrinologists/American College of Endocrinology, metformin is recommended as a first-line agent for monotherapy and combination therapy for patients with type 2 diabetes mellitus (T2DM)
Patients whose glycaemic control deteriorates over time with metformin monotherapy will require additional anti-diabetic medication
Dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of oral anti-diabetic agents that increase circulating concentrations of the incretin gastrointestinal hormones glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide [5]
Summary
According to statements by the American Diabetes Association/European Association for the Study of Diabetes and the American Association of Clinical Endocrinologists/American College of Endocrinology, metformin is recommended (unless contraindicated) as a first-line agent for monotherapy and combination therapy for patients with type 2 diabetes mellitus (T2DM). This recommendation is based primarily on metformin's glucose lowering effects, absence of weight gain, generally low level of side effects, and relatively low cost [1,2]. In a 24-week study in patients whose diabetes was not adequately controlled by stable metformin doses, adding saxagliptin 2.5, 5, or 10 mg daily reduced HbA1c from a baseline of 8.1%, by 0.7, 0.8, and 0.7%, respectively, compared with add-on placebo [7]
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