Green Solvent Assisted UV–Spectrophotometric Method for Estimation of Efonadipine Hydrochloride Ethanolate in Bulk and Pharmaceutical Dosage Form

A green solvent-assisted UV-spectrophotometric method has been developed and validated for the estimation of Efonidipine HCl Ethanolate in bulk and pharmaceutical dosage forms using Isopropyl alcohol as the solvent. Isopropyl alcohol, classified as a Class 3 solvent according to ICH Q3C guidelines, offers a safer and environmentally friendly alternative with minimal toxicity concerns. The method involves the measurement of absorbance at 251 nm the maximum wavelength (λmax) of Efonidipine HCl Ethanolate using a UV-visible spectrophotometer. Validation of the method, as per ICH Q2(R1) guidelines, confirmed its accuracy, precision, linearity, and robustness. The linearity of the method was satisfactory over the range of 5 – 25 μg/mL (Correlation coefficient: 0.9976). The %RSD for repeatability for sample measurement and sample application was found to be 0.693 and 0.636 respectively. The %RSD for Intra-day and Inter-day precision was found to be 0.200-0.987% and 0.213-1.192% respectively. The LOD and LOQ for EFO were found to be 0.612 and 1.856 respectively. Recovery of Efonidipine HCl ethanolate ranged from 98.89-100.43%. The method was successfully applied to the marketed formulation for quantitative analysis of Efonidipine HCl ethanolate. The assay result was found to be 99.82% for Efonidipine HCl ethanolate. The proposed method is simple, cost-effective, and sustainable, making it suitable for routine quality control analysis while adhering to the principles of green chemistry.