High Performance Thin Layer Chromatography method for estimation of Rosuvastatin Calcium and Teneligliptin Hydrobromide Hydrate from its tablet dosage form

Fixed dose combination of Rosuvastatin and Teneligliptin Hydrobromide Hydrate is proposed to reduce the risk of heart disease and stroke in patient with type 2 Diabetes mellitus and Dyslipidemia disease. The two-drug combination yield significant reduction in plasma glucose and low-density lipoprotein level in patient according to the data from clinical trial in Synokem Pharmaceutical LTD. Delhi, India. A simple, precise and accurate HPTLC method has been developed and validated for quantitative determination of Rosuvastatin Calcium and Teneligliptin Hydrobromide Hydrate from its tablet formulation. The method involved separation of components on a pre- coated TLC silica gel 60 F254 plate using a mixture of Toluene: Methanol: Ethyl acetate: Glacial acetic acid: Triethanolamine (5: 3: 2: 0.1: 0.1 v/v/v/v/v) as a mobile phase. Detection of spots was carried out at 246 nm for Rosuvastatin Calcium and Teneligliptin Hydrobromide Hydrate both. The mean Retardation factor for Rosuvastatin Calcium & Teneligliptin Hydrobromide Hydrate found to be 0.86 + 0.011 and 0.25 + 0.003, respectively. The Linear regression data for the calibration plots showed good linear relationship with R2 value 0.996 & 0.999 in the concentration range of 1-5 μg/band and 2-10 μg/band for Rosuvastatin Calcium & Teneligliptin Hydrobromide Hydrate respectively. The developed method was then validated as per ICH Q2 R2 guidelines.