Eco-Friendly UV Spectroscopic and RP-HPLC Methods for Simultaneous Estimation of Efonidipine Hydrochloride Ethanolate and Telmisartan: A DOE-Optimized Approach with Greenness and Whiteness Assessment
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An accurate, simple and environment friendly Ultraviolet-visible spectroscopic method and Reverse phase High performance liquid chromatography method was established for simultaneous estimation of Efonidipine Hydrochloride Ethanolate and Telmisartan in their pharmaceutical dosage form. Ultraviolet-visible spectroscopic method utilized the simultaneous equation method using 251 nm and 296 nm wavelengths for Efonidipine Hydrochloride Ethanolate and Telmisartan, respectively. Reverse phase high performance liquid chromatography was optimizing with the help of Central Composite Design which is a Design of Experiment approach, to accomplish optimal separation of both drugs with using minimum solvent. Optimal chromatographic separation was obtained by Shimandzu C18 column (250 × 4.6 mm, 5 µm) with Mobile phase which comprising Ethanol: Acetonitrile: Water (70:20:10%v/v) at pH 4, flow rate 1 ml/min at detection wavelength 250 nm. Both methods were validated as per ICH Q2 (R1) guideline, showing linearity, precision, accuracy, limit of detection, limit of quantification. Assessment of greenness and whiteness score, ensures that methods have environmental sustainability and analytical efficiency.