Development and validation of the HPLC-procedure for the quantitative determination of isosorbide dinitrate in matrix granules

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.