以寧海都寧配合分光光度法檢測藥品中利欣諾普之含量   全文下載

Spectrophotometric Determination of Lisinopril in Pharmaceuticals Using Ninhydrin- a Modified Approach

本研究係以分光光度法於波長420 nm 處分析利欣諾普（lisinopril）與寧海都寧（ninhydrin）（bicarbonate 共存時）反應形成之黃色產物，反應在97 ± 1° C 持續10 分鐘。檢量線於5.0-50.0 μg/mL 濃度範圍內呈線性相關，A = （-） 0.0175 + 0.0079C，迴歸係數r 為0.9979（n = 6）。莫耳吸收度和Sandell sensitivity 值分別為2.02 × 103 L/mol/cm 及0.219 μg/cm2。LOD 和LOQ 分別為 0.68 及2.07 μg/mL。同日間分析誤差值低於2.5%，RSD 值介於1.02~1.93%；異日間分析誤差值低於4.0%，RSD 值介於1.5~3.0%。應用本方法於分析三種含利欣諾普的錠劑，其分析結果與使用BP 法相同，本法亦可確認利欣諾普在水溶液中之穩定性。

An accurate and precise spectrophotometric method is presented for the determination of lisinopril based on the formation of a yellow colour product with ninhydrin in the presence of bicarbonate with an absorption maximum at 420 nm. The reaction proceeds quantitatively at 97 ± 1°C in 10 min. The calibration curve is linear over the range of 5.0-50.0 μg/mL and is described by the regression equation A = (-) 0.0175 + 0.0079 C with a regression coefficient (r) of 0.9979 (n = 6). The calculated molar absorptivity and Sandell sensitivity values are 2.02 × 103 L/mol/cm and 0.219 μg/cm2, respectively. The limits of detection (LOD) and quantification (LOQ) calculated as per ICH guidelines are 0.68 and 2.07 μg/mL, respectively. The within-day accuracy expressed as relative error was better than 2.5% with precision (RSD) ranging from 1.02 to 1.93%. The between-day accuracy ranged from 1.5-3.0% with a precision less than 4%. The method was successfully applied to the analysis of three brands of tablets containing lisinopril. The results obtained were in agreement with those obtained by the BP method. Accuracy was also checked by placebo blank and synthetic mixture analyses besides a recovery study via standard addition procedure. The method was also used to check the stability of lisinopril in solution.