Method Development and Method Validation of Phosphodiesterase-5 Inhibitor (PDE5-I) and Anti-Diabetic in Diabetic Nephropathy in Animal Model Using RP-HPLC Method
Abstract
Method Development and Method Validation using RP-HPLC Method For Metformin Hydrochloride (MET), Tadalafil (TAL) In Rat Plasma-Application to The Pharmacokinetic Studies, Metformin hydrochloride (MET) is an oral anti-diabetic drug in the biguanide class for the treatment of type 2 diabetes mellitus. Tadalafil (TAL) is a medication used to treat erectile dysfunction and other conditions. For the pharmacokinetic study of MET and TAL, and we developed a simple and sensitive method for estimating MET and TAL in rat plasma using reverse phase high-performance liquid chromatography (RP-HPLC). The drug samples were extracted using solid phase extraction with a stationary-phase strata-X Cartridges and a 1ml mixture of mobile phase. Chromatographic separation was accomplished on a C18 column using (0.3) Triethyl anime buffer: methanol: acetonitrile (70:05:25 v/v) as mobile phase at a flow rate of 1ml/min and UV detection at 224nm. The retention time of MET. The TAL values were found respectively, with a 15-minute separation time. The developed method underwent validation for accuracy, precision, linearity, and recovery. Linearity studies were found to be acceptable between 0.4 and 6.4 ug/ml. The method was successfully applied to analyze rat plasma samples for pharmacokinetic studies, drug interactions, bioavailability, and bioequivalence.
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