Abstract
Isosorbide dinitrate is a universally recognized drug for the relief of angina attacks. Today, prolonged forms of isosorbide dinitrate are of great interest due to their high antianginal efficacy and lower frequency of side effects that are characteristic for drugs with immediate release.Aim. To develop the procedure for the quantitative determination of isosorbide dinitrate in matrix granules using high performance liquid chromatography and validate it.Results. To determine isosorbide dinitrate by the method of high performance liquid chromatography with UV-detection the optimal chromatographic conditions were selected taking into account the effect of excipients in the composition of the medicine. To prove the possibility of applying the procedure proposed in the further analysis of matrix granules of isosorbide dinitrate its validation was carried out. Such validation parameters as specificity, linearity, repeatability, accuracy, intermediate precision, limit of detection and limit of quantification, robustness were assessed using model solutions.Experimental part. The chromatographic researches were performed using liquid chromatograph Shimadzu LC-20AD XR with diode-array detector under the following conditions: chromatographic column – Supelco Discovery C18 (150 × 4.6 мм, 5 мкм); mobile phase – water R – buffer solution with (pH 4.7) – methanol R2 (35:10:55); elution mode – isocratic; flow rate of the mobile phase – 1.0 mL/min.; detection wavelength –220 nm; software – LCsolution, 1.24.SP.1 version.Conclusions. A new procedure for the quantitative determination of isosorbide dinitrate in matrix granules has been developed using high performance liquid chromatography. Its validation has been carried out, and its acceptability has been proven.
Highlights
Хроматографічні дослідження проводили на рідинному хроматографі Shimadzu LC-20AD XR з діодно-матричним детектором за таких умов: хроматографічна колонка Supelco Discovery C18 (150 × 4,6 мм, 5 мкм); рухома фаза – вода Р – буферний розчин – метанол Р2 (35:10:55); режим елюювання – ізократичний; швидкість рухомої фази – 1,0 мл/хв; довжина хвилі детектування – 220 нм; програмне забезпечення – LCsolution, версія 1.24.SP.1
Today, prolonged forms of isosorbide dinitrate are of great interest due to their high antianginal efficacy and lower frequency of side effects that are characteristic for drugs with immediate release
To determine isosorbide dinitrate by the method of high performance liquid chromatography with UV-detection the optimal chromatographic conditions were selected taking into account the effect of excipients in the composition of the medicine
Summary
Відносне стандартне відхилення sz, % Відносний довірчий інтервал Dz, % = t(95 %, 8)·sz = 1,8596·sz Критичне значення для збіжності результатів Dz, % ≤ 1,6 Систематична похибка d = |Z – 100|. Критерій незначущості систематичної похибки: 1) d ≤ Dz /3 = 0,61/3 = 0,20; 2) якщо не виконується 1), то d ≤ maxd = 0,51. 0,61 виконується 0,04 виконується виконується рахованим критеріям; методика лінійна в досліджуваному діапазоні концентрацій – від 80 % до 120 % по відношенню до номінального вмісту ізосорбіду динітрату
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
