Paper Details
Method Development and Validation of Stability Indicating RP- HPLC Method Using Iron Chelating Agent
Authors
Lalita N. Patil, Syed S. Ali
Abstract
The ideal of this present is to develop a simple, precise, accurate stability indicating system for the estimation of deferiprone in expression by using RP- HPLC.
The system was validated for delicacy, perfection, particularity, linearity and perceptivity. The total chromatographic analysis time per sample was about 5 min with deferiprone eluting at retention time of about 4.980 min.
The system was validated as per ICH companion lines. Stability studies reported absence of contaminations at the peak retention time. The medicine was stable to different conditions like acidic, alkali, thermal, oxidative conditions.
Confirmation studies demonstrated that the proposed HPLC system is simple, specific, rapid-fire, dependable and reproducible. The standard angles were direct over the attention range of 75- 125µg/ ml. The LOD and LOQ values for deferiprone were 0.14 and 0.45 µg/ mL, independently. The chance recovery was set up to be 0.77, 0.407, and 0.7023 at 80, 100, and 120 independently and the RSD for perfection was set up to be 0.78, 0.408, and 0.7028 independently.
The high recovery and low relative standard divagation confirm the felicity of the proposed system for the determination of deferiprone in bulk and capsule lozenge forms.
Keywords
RSD: Relative standard deviation, LOD: Limit of detection, SD: Standard deviation ICH: International Conference on Harmonization, UV: Ultraviolet, Rt: Retention Time, API: Active Pharmaceutical Ingredient, LOQ: Limit of Quantitation, RP: HPLC: Reversed Phase High Performance Liquid Chromatography, SIAM: Stability indicating assay method
Citation
Method Development and Validation of Stability Indicating RP- HPLC Method Using Iron Chelating Agent. Lalita N. Patil, Syed S. Ali. 2024. IJIRCT, Volume 10, Issue 6. Pages 1-17. https://www.ijirct.org/viewPaper.php?paperId=2412111