Stability indicating densitometric analysis for simultaneous estimation of Dapagliflozin propanediol monohydrate and Telmisartan

This present study reports for the first-time development and validation of stability indicating high performance thin layer chromatographic simultaneous Estimation of Dapagliflozin propanediol monohydrate and Telmisartan combined dosage form by employing High Performance Thin Layer Chromatographic method. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 G F254 as the stationary phase and the mobile phase used was a mixture of Ethyl acetate: Toluene (8:2, v/v). Densitometric evaluation of the separated bands was performed at 236 nm. The RF values for Dapagliflozin propanediol monohydrate and Telmisartan were found to be 0.19 and 0.41 respectively. The calibration curve was found to be linear between 200 and 500ng/band for Dapagliflozin propanediol monohydrate and between 800 and 2000ng/band for Telmisartan. The method was validated as per (ICH)Q2 (R2) guidelines for accuracy, precision, robustness, specificity, limit of detection and limit of quantitation. A forced degradation study was performed to assess the stability indicating the nature of the method. As the method could effectively separate the drugs from its degradation products, it can be employed as a stability indicating method. The developed method can be successfully employed for the simultaneous estimation of these drugs in tablet formulation.