Development and validation of simultaneous estimation of drugs in combination from pharmaceutical formulation by RP-HPLC method

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.