Abstract
Background: Methods were not available in the monographs like United States Pharmacopeia, British pharmacopeia and European pharmacopeia and also in the literature for the determination of three related impurities namely Impurity A, B and C in Felodipine solid dosage form with a shorter runtime using RP-HPLC. Method: A simple RP- HPLC method was developed and validated for the quantification of Felodipine Impurity A, B and C in Felodipine solid dosage form and in drug substance. This method was developed on waters alliance using Phenomenex Gemini column C18 5 μm,150 × 2.0 mm i.d, using the isocratic program with the mobile phase ratio of 0.02 mM ammonium acetate adjusted to pH 5 and acetonitrile (55:45,v/v) with a flow rate of 0.7 mL/min. The λmax is at 240 nm. Results: Forced degradation was performed as per ICH guidelines and no interference of the impurities with the known peaks was found. Precision was found between 0.1 and 0.2%. The Limit of detection and quantification for Felodipine and impurity A; Impurity B and C were 0.05 and 0.15 μg/mL respectively. The linearity correlation coefficient was found to be >0.999 for Impurity A and Felodipine; Impurity B and C of concentration range 0.2-30.0 μg/mL and 0.2-8.0 μg/mL respectively. The method accuracy was assessed for Felodipine and its impurities at four levels (LOQ, 50%, 100% and 150%) and the recovery ranged from 95% to 106%. Conclusion: The method was found to be precise, reliable, accurate and robust.
Highlights
Hypertension is an important risk factor for atherosclerosis and the beneficial effects of lowering blood pressure on the vascular morbidity and mortality is well documented and demonstrated
The method accuracy was assessed for Felodipine and its impurities at four levels (LOQ, 50%, 100% and 150%) and the recovery ranged from 95% to 106%
Felodipine (FD) is chemically referred to as 3-ethyl 5-methyl 4-(2,3-dichlorophenyl) -2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic is an antihypertensive drug with molecular formula C18H19Cl2NO4 and molecular weight 384.254 g/mol (Table 1) [1,2]
Summary
Hypertension is an important risk factor for atherosclerosis and the beneficial effects of lowering blood pressure on the vascular morbidity and mortality is well documented and demonstrated. FD may be used to treat mild to moderate essential hypertension [3] FD, a new generation calcium channel antagonist, belonging to the class of dihydropyridines, is a practical advance in the treatment of hypertension [4,5]. FD is a highly vasodilative calcium antagonist that effectively reduces arterial blood pressure [6]. There were no methods listed in the USP, EP and BP monographs as well as in the literature for the determination of three impurities namely Impurity A (Imp A), Impurity B (Imp B) and Impurity C (Imp C) in FD solid dosage form with shorter runtime. Methods were not available in the monographs like United States Pharmacopeia, British pharmacopeia and European pharmacopeia and in the literature for the determination of three related impurities namely Impurity A, B and C in Felodipine solid dosage form with a shorter runtime using RP-HPLC
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
