LAUSR

INTRODUCTION: Objectives: Two optimized and validated HPLC and spectrophotometric methods were proposed. The developed methods were quantified with high sensitivity, accuracy, and precision at low concentrations to determine rufinamide in active pharmaceutical ingredient (API) and pharmaceutical preparations. METHODS: Materials and Methods: HPLC method was developed using BDS Hypersil C18 column and combination of methanol: acetonitrile: water (15: 10: 75, v/v/v) as mobile phase and detected at 210 nm. A reaction of rufinamide with sodium nitrite and hydrochloric acid took place, absorbed maximally at 385 nm was extended to develop a UV-visible spectrophotometric method to determine rufinamide in API and pharmaceutical preparations. RESULTS: Results: Different analytical validation parameters include specificity, linearity, accuracy, precision, the limit of detection, quantification, ruggedness, and robustness, were determined as per International Conference on Harmonisation (ICH) guidelines. The linearity range of rufinamide was 0.15-3.5 and 10-100 μg/mL for HPLC and spectrophotometric method, respectively. DISCUSSION AND CONCLUSION: Conclusion: The statistical analyses disclosed no significant differences between the acquired results and reported ones. The proposed investigations were valuable for drug monitoring and regular analysis of rufinamide in quality control and research laboratories. Moreover, the accuracy and precision obtained with the UVVisible spectrophotometry implied that it could be a cheap, easy, and alternative method, while the HPLC could be a sensitive one to determine rufinamide with low concentration levels.