DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SIMVASTATIN AND FENOFIBRATE IN BULK AND DOSAGE FORM | ||
| Bulletin of Faculty of Science, Zagazig University | ||
| Article 13, Volume 2025, Issue 3, July 2025, Pages 134-146 PDF (908.14 K) | ||
| Document Type: Original Article | ||
| DOI: 10.21608/bfszu.2025.343593.1456 | ||
| Authors | ||
| Ayman A Gouda* 1; Ragaa elsheikh2; Ahmed Salah Eldien2; Ahmed Sobhy Darwish3 | ||
| 1Chemistry Department, Faculty of Science, Zagazig University, Zagazig, Egypt | ||
| 2Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt. | ||
| 31 Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt. | ||
| Abstract | ||
| In a present study rapid, simple and novel isocratic reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed with stability indicating potential for simultaneous estimation of simvastatin (SMV) and fenofibrate (FNO) in bulk and dosage form. The chromatographic elution was performed on Restek, Pennacle C18 (5 μm, 150 mm × 4.6 mm i.d.) column as stationary phase and mobile phase consists of acetonitrile:(buffer: 6.67 mM monobasic sodium phosphate and 5.1 mM orthophosphoric acid, pH = 2.5), (75:25, v/v) at flow rate 1.5 mL/min pumped through a column maintained at ambient temperature (about 25°C) and injection volume 20.0 µl with a response observed at 250 nm over an 5.0 min run time. The simvastatin and fenofibrate were eluted at 3.869 min and 4.778 min, respectively. The method was validated according to the International Conference on Harmonization (ICH) guideline Q2 (R1). The method was linear: 8.0–28 µg/mL (R2 = 0.9993) for simvastatin and 58-203 µg/mL (R2 = 0.9991) for fenofibrate. Limit of detection (LOD) were 1.19 and 0.13 µg/mL, while Limit of quantitation (LOQ) were 3.60 and 0.41 µg/mL for simvastatin and fenofibrate, respectively. The percentage recovery average at three different levels was ranged from 98.51 to 101.64% for simvastatin and 98.45 to 101.33% for fenofibrate. The % RSD value was ≤1.10% during the precision study. Additionally, the method is stability indicating, as it was able to distinguish the degraded product generated during forced degradation from active analytes. The method can be used successfully for stability study and routine analysis. | ||
| Keywords | ||
| RP-HPLC; Stability-indicating; Simvastatin; Fenofibrate; Dosage form | ||
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