Annales pharmaceutiques francaises · 2018
Validated RP-HPLC method for quantification of felodipine in rabbit plasma: Application in a bioequivalence study.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
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Salunkhe N H, Jadhav N R, Bhinge S D
Аннотация
OBJECTIVE: The aim of present study was to develop a simple, rapid, selective, sensitive and robust reverse phase high performance liquid chromatographic method for quantification of felodipine in rabbit plasma at the wavelength of 360nm.
METHOD: Protein was precipitated from rabbit plasma sample by addition of acetonitrile as a vehicle. An isocratic elution of samples was performed on capcell pak C8 DD S5 column (4.6mm×250mm particle size 5μm) column with mobile phase consisting 5mM Phosphate Buffer (pH 4.8 adjusted with dilute ortho-phosphoric acid solution): acetonitrile (25:75:v/v) delivered at flow rate 1.0mLmin-1.
RESULT: A good linear response was achieved over the range of 0.25-20.00μgmL-1. LODs and LOQs for felodipine were found to be 0.055 and 0.201μgmL-1, respectively. The method was quantitatively evaluated in terms of linearity, precision, accuracy (recovery), selectivity robustness and stability study as per standard guidelines. The validated RP-HPLC method was successfully applied for the bioavailability studies of felodipine. The pharmacokinetic parameters were calculated for all the investigated drugs in rabbit after single-dose administrations of pure drug and formulation of felodipine. Finally, the obtained results for the application of the proposed RP-HPLC method proved its efficiency to be applied to the therapeutic drug monitoring (TDM) and bioequivalence (BE) studies.
CONCLUSION: Thus, developed method is simple, convenient and suitable for the analysis of felodipine in bulk and pharmaceutical formulations.
METHOD: Protein was precipitated from rabbit plasma sample by addition of acetonitrile as a vehicle. An isocratic elution of samples was performed on capcell pak C8 DD S5 column (4.6mm×250mm particle size 5μm) column with mobile phase consisting 5mM Phosphate Buffer (pH 4.8 adjusted with dilute ortho-phosphoric acid solution): acetonitrile (25:75:v/v) delivered at flow rate 1.0mLmin-1.
RESULT: A good linear response was achieved over the range of 0.25-20.00μgmL-1. LODs and LOQs for felodipine were found to be 0.055 and 0.201μgmL-1, respectively. The method was quantitatively evaluated in terms of linearity, precision, accuracy (recovery), selectivity robustness and stability study as per standard guidelines. The validated RP-HPLC method was successfully applied for the bioavailability studies of felodipine. The pharmacokinetic parameters were calculated for all the investigated drugs in rabbit after single-dose administrations of pure drug and formulation of felodipine. Finally, the obtained results for the application of the proposed RP-HPLC method proved its efficiency to be applied to the therapeutic drug monitoring (TDM) and bioequivalence (BE) studies.
CONCLUSION: Thus, developed method is simple, convenient and suitable for the analysis of felodipine in bulk and pharmaceutical formulations.