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

A green solvent-assisted UV-spectrophotometric method has been developed and validated for the estimation of ranolazine 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 274 nm the maximum wavelength (λmax) of ranolazine 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 10 - 50 μg/mL (Correlation coefficient: 0.9955). The %RSD for repeatability for sample measurement and sample application was found to be 1.201 and 0.996 respectively. The %RSD for Intra-day and Inter-day precision was found to be 0.380 – 1.364 % and 0.328 – 1.219 % respectively. The LOD and LOQ for Ranolazine were found to be 0.902 and 2.733 respectively. Recovery of Ranolazine ranged from 99.56 -100.01 %. The method was successfully applied to the marketed formulation for quantitative analysis of Ranolazine. The assay result was found to be 99.36 % for Ranolazine. 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.