Lisinopril dihidrat ve safsızlıklarının eş zamanlı analizi içinyeni HPLC-DAD ve HPLC-ELSD yöntemlerinin geliştirilmesi vevalidasyonu

This thesis provides the development and validation of robust analytical approaches for the determination of lisinopril dihydrate (LSDH) and its impurities (A and D) in both active pharmaceutical ingredients and tablet preparations. Two HPLC methods, HPLCDAD and HPLC-ELSD, were developed and systematically validated. Their performance was evaluated using a 250 × 4.6 mm, 5 µm C18 column. The HPLC-DAD analysis was performed at a flow rate of 1.00 mL/min using a mobile phase consisting of a 60:40 (v/v) mixture of 23 mM phosphate buffer (pH 9.50) and methanol. Detection was performed at 210 nm using a DAD detector. For HPLC-ELSD analysis, a mobile phase consisting of water and methanol in a 60:40 (v/v) ratio was used at a flow rate of 1.00 mL/min. Detection was performed using an ELSD detector set at 60°C, with gain and filter settings of 7 and 2, respectively. The injection volume was set to 10 µL for both methods. - The findings obtained from the statistical evaluation demonstrated that both techniques used to measure LSDH yielded comparable results without significant differences. Both methods exhibited excellent selectivity, stability, and sensitivity, thereby confirming their effectiveness in accurately determining LSDH and related impurities (A and D) in pharmaceutical tablet formulations. In general, the use of modern chromatographic systems such as HPLC-DAD and HPLC-ELSD enhances analytical reliability, strengthens therapeutic value, and ensures compliance with pharmaceutical regulations.