Objective: Effective and precise method utilizing high-performance liquid chromatography (HPLC) has been created and rigorously validated to quantify Rizatriptan Benzoate and Naproxen Sodium within a combined bulk drug. Rizatriptan Benzoate acts as an agonist, interacting with serotonin 5-HT1B and 5-HT1D receptors. In contrast, Naproxen Sodium's role involves inhibiting COX-1, associated with potential gastrointestinal and renal side effects, while COX-2 inhibition contributes to its anti-inflammatory properties. This combination finds application in treating migraine. The separation of the compounds was executed utilizing a Waters ODS C18 Column (4.6 × 250 mm, 5 µm particle size). The mobile phase, composed of Phosphate buffer (pH 3), Acetonitrile, and Methanol in a 30:45:25 v/v ratio, flowed at 1 ml/min, with detection achieved at 232 nm. Both Rizatriptan Benzoate and Naproxen Sodium exhibited excellent linearity over concentrations of 0.5–4 µg/ml and 20–40 µg/ml, respectively. The correlation coefficients for both compounds were high, measuring 0.999 and 0.998. Key outcomes include retention times of 2.46 min for Rizatriptan Benzoate and 5.97 min for Naproxen Sodium. Validation encompassed various aspects such as system suitability, linearity, precision, accuracy, specificity, robustness, solution stability, limit of detection (LOD), limit of quantification (LOQ), and forced degradation. All parameters met the acceptable criteria outlined by ICH guidelines. In conclusion, this newly developed HPLC method is well-suited for the routine quality control of Rizatriptan Benzoate and Naproxen Sodium in both combined bulk drug and formulations. Its accuracy, sensitivity, and reliability make it an invaluable tool for ensuring the consistent quality of these compounds in various applications.

Mrs. Ashwini Wani*, Dr. Anita Ayre, Ms. Madri Renu Rangaswami Mariem

HPLC, Migraine, Rizatriptan benzoate, Naproxen sodium, Validation