Concurrent Analysis of Racecadotril, Ofloxacin, and Ornidazole in a Fixed‐Dose Combination by RP‐HPLC–DAD Method

ABSTRACT

The pharmaceutical combination of Racecadotril (RAC), Ofloxacin (OFL), and Ornidazole (ORN) is a commonly prescribed treatment for diarrhea and dysentery in pediatric patients. A rapid and highly sensitive reverse phase–high‐performance liquid chromatography–diode array detector (RP‐HPLC–DAD) method has been established for the concurrent analysis of all three drugs in a combined oral suspension. Drugs were separated by chromatography using a Sapphire octadecylsilane (ODS) C18 (150 × 4.6 mm, 5 µm) column, operated at 30°C. The elution solvent consisted of a mixture of acetonitrile and 0.1% triethylamine solution (70:30 v/v), with the pH adjusted to 3.1 using 10% orthophosphoric acid. The flow rate was maintained at 1 mL/min, and all three drugs were monitored at 230 nm. The method showed linearity within the ranges: RAC (3–9 µg/mL), OFL (10–30 µg/mL), and ORN (25–75 µg/mL). Retention times were 2.03 min for OFL, 2.99 min for ORN, and 6.99 min for RAC. The drug content for RAC, OFL, and ORN ranged from 100.92% to 101.39%, 98.55% to 100.76%, and 99.33% to 101.22%, respectively, with recoveries of 96.33%–102.16%, 97.50%–101.32%, and 98.25%–100.76%, and %RSD values consistently below 2 in within‐day, between‐day, and repeatability studies, demonstrating method precision. The projected chromatography technique has been authenticated in line with International Council on Harmonization Q2 (R1) guidelines. This approach offers a short runtime of 10 min, providing an economically efficient chromatographic technique for the concomitant assessment of RAC, OFL, and ORN in a combined oral suspension preparation.