ABSTRACT
A sensitive, reproducible and modest analytical procedure was developed and validated for evaluation of irbesartan in human plasma. LLE (Liquid-Liquid extraction) of the drug was carried out with acetonitrile (1:1 v/v). Chromatographic separation of irbesartan was conducted by the help of 4.0mm × 25cm column having L1 packing from plasma and mobile phase utilizing HPLC. The mobile phase comprise of phosphate buffer and acetonitrile in a ratio of 67:33 v/v. The flow rate was set at 1ml/minute and the detector at a wavelength of 220 nm. The resolution of irbesartan was well performed from plasma components. This method was validated and demonstrated linearity with a concentration range of 0.1to 6µg/ml of irbesartan in plasma. Intra-day, inter-day accuracy was found 89.33% to 96.37% while intra-day, inter-day precision was found within the limit of 0.02 and 2.15 respectively. The mean recovery of irbesartan was 97.28%. The efficacy of extraction was proved by above-mentioned results. In plasma, the 0.05 and 0.1µg/ml dilutions were exhibited as the LOD and LOQ of irbesartan. Stability studies disclosed that irbesartan showed stability at -20°C storage.
Subject(s)
Angiotensin II Type 1 Receptor Blockers/blood , Chromatography, High Pressure Liquid/methods , Irbesartan/blood , Angiotensin II Type 1 Receptor Blockers/pharmacokinetics , Calibration , Chromatography, Reverse-Phase/methods , Drug Stability , Humans , Irbesartan/pharmacokinetics , Limit of Detection , Sensitivity and SpecificityABSTRACT
A simple, sensitive and rigorous method for estimation of dimenhydrinate in human plasma was searched and its validation was carried out. LLE (Liquid-Liquid extraction) of analyte with mixture of Hexane and ethyl acetate (1:1 v/v) was carried out for the preparation of Plasma Samples, Chromatographic elution of dimenhydrinate was conducted in human plasma and mobile phase with C-18 bonda Pack column (10µm; 250 × 4.6), using a mobile phase consisting a solution of ammonium bicarbonate in water and methanol at a flow rate of 0.5ml/minute with UV detection at 229 nm. The resolution of dimenhydrinate was well performed from plasma components. This method was validated and exhibited linearity with concentration range of 6 to 380ng/ml of dimenhydrinate in plasma. The Intra day precision was 89.2 to 96.89% and Inter day precision was 88.6% to 93.26%, the average recovery of dimenhydrinate was 97.02%. The efficacy of extraction was proved by above mentioned results. 2ng/ml and 6ng/ml, were appraised as the LOD and LOQ of dimenhydrinate, stability studies disclosed that dimenhydrinate exhibited stability in Plasma after Freeze & thaw cycles and upon -20°C storage, the method was developed well.