Stability Indicating Method Development And Validation For The Determination Of Felodipine Raw Material And Degradant Products By Utilizing Reversed Phase Liquid Chromatography

Stability Indicating Method Development and Validation for the Determination of Felodipine Raw Material and Degradant Products by Utilizing Reversed-phase Liquid Chromatography

"Felodipine, USP is a dihydropyridine calcium antagonist. The brand names for Felodipine are Feloday, Plendil, and Hydec. It is described as an antihypertensive vasodilator agent. A stability indicating reversed phase high performance liquid chromatography has been developed and validated for the determination of Felodipine in a raw material. Agilent 1100 series high performance liquid chromatography system was used for method development studies. The separation was performed on Phenomenex Synergi C18 (4μm), 150 x 4.6 mm column with flow rate 1 mL/min at 25°C column temperature. Isocratic elution was carried out with mobile phase consisted of Solvent A (25mM mono-basic Potassium Dihydrogen Phosphate, pH 2.5) and Solvent B (50% ACN). The UV detection wavelength was set at 235 nm. The stability study of Felodipine was carried out by forced degradation using hydrochloric acid, sodium hydroxide, hydrogen peroxide, UV light, and heat. The correlation coefficient was 0.9996 which indicates linear regression curve. The percentage recovery of the method was 99-100%. The percentage RSD for method precision for peak area and retention time was 1.12 and 0.42, respectively. (n=6). The LOD and LOQ result was found to be 0.01 ppm and 0.05 ppm respectively. The developed method is specific, linear, precise, accurate, and robust based on validation results according to ICH guidelines."--

Development and Validation of Stability Indicating Method for the Determination of Nimodipine and Its Possible Degradation Products Using Reverse-phase Liquid Chromatography

"Nimodipine is the latest Calcium channel blocker. It is used for the prevention of major complications of subarachnoid hemorrhage called vasospasm. A simple, linear, accurate, precise, robust reversed-phase HPLC method was developed for the determination of nimodipine raw material on Alltech Krommacil C18 column (250 × 4.6 mm × 5 μm) using mobile phase 50% ACN and 50% Potassium Phosphate Monobasic buffer 25mM at pH 2.5. Total run time was 30 min, flow rate was 1ml/min, injection volume was 10μl and detection wavelength was 237nm. Degradation study was done under different stress conditions: acid hydrolysis, base hydrolysis, oxidation, UV light, heat. The optimum degradation was obtained with 2M HCl, 0.1M NaOH heated for 6hr and 0.5% H2O2 heated for 2hr. Moreover, the developed method was validated as per ICH guidelines for system suitability, specificity, stability, robustness, linearity, accuracy, precision, also for limit of detection and limit of quantitation and this method met all the acceptance criteria."--

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