Irbesartan is an antihypertensive drug whose concentration in blood is very small so it requires a sensitive method of analysis, selective and valid for analysis. In this study, it is carried out optimization of analy...Irbesartan is an antihypertensive drug whose concentration in blood is very small so it requires a sensitive method of analysis, selective and valid for analysis. In this study, it is carried out optimization of analytical conditions and validation for the analysis of irbesartan in plasma. Chromatography was performed on a C 18 column （250 × 4.6 mm, 5 μm） under isocratic elution with acetonitrile-0.1% formic acid （46：54 v/v）, pH 3.75. Detection was made at excitation 250 nm and emission 370 nm and analyses were run at a flow-rate of 1.0 mL/min at a temperature of 40 ℃. Losartan potassium was used as internal standard. Plasma extraction was done by deproteination with acetonitrile, mixed with vortex for 30 seconds, then centrifuged it at 10,000 rpm for 10 rain. In plasma validation, the recovery was 96.22%, and the lower limit of quantification （LLOQ） in plasma was 2 ng/mL. The method also fulfill the criteria for accuracy and precision intra and inter day by normal values （%Diff） not exceed ± 15%. On the stability study, irbesartan in plasma temperature -20 ℃has been stable for 28 days.展开更多
文摘Irbesartan is an antihypertensive drug whose concentration in blood is very small so it requires a sensitive method of analysis, selective and valid for analysis. In this study, it is carried out optimization of analytical conditions and validation for the analysis of irbesartan in plasma. Chromatography was performed on a C 18 column （250 × 4.6 mm, 5 μm） under isocratic elution with acetonitrile-0.1% formic acid （46：54 v/v）, pH 3.75. Detection was made at excitation 250 nm and emission 370 nm and analyses were run at a flow-rate of 1.0 mL/min at a temperature of 40 ℃. Losartan potassium was used as internal standard. Plasma extraction was done by deproteination with acetonitrile, mixed with vortex for 30 seconds, then centrifuged it at 10,000 rpm for 10 rain. In plasma validation, the recovery was 96.22%, and the lower limit of quantification （LLOQ） in plasma was 2 ng/mL. The method also fulfill the criteria for accuracy and precision intra and inter day by normal values （%Diff） not exceed ± 15%. On the stability study, irbesartan in plasma temperature -20 ℃has been stable for 28 days.
