Psikoaktif bir ilacın HPLC-DAD dedektörü ile safsızlık analizi

In this research, an HPLC-DAD technique was validated for the identification of impurities A and F in lamotrigine, a psychoactive drug. The study includes a comparative analysis of three pharmaceutical samples obtained from different countries. A C18 Phenomenex column with a dimension of 4.6 × 250 mm and a 4 μm particle size was utilized in the method. The gradient elution was used with mobile phase A consisting of monobasic potassium phosphate buffer (pH 3.5) and mobile phase B containing acetonitrile, at a flow rate of 1.0 mL/min and a column temperature of 40°C. Impurities were detected using diode array detection (DAD) at 215 nm. The injection volume for the HPLC-DAD analysis was 10 μL. The method was validated with precision, accuracy, linearity, limit of detection (LOD), limit of quantification (LOQ), specifity, robustness and stability. The method exhibited good linearities over the studied concentration ranges (r2> 0.999). The limit of detection (LOD) and limit of quantification (LOQ) for Impurity-A were determined as 0.030 μg/mL and 0.09 μg/mL, respectively. For Impurity-F, these values were found to be 0.019 μg/mL and 0.058 μg/mL, respectively. The method demonstrated high selectivity and stability, making it ideal for determining impurities A and F in lamotrigine drug formulations. The results are reliable, thereby contributing to quality control in the pharmaceutical industry for determining related compounds in commercial lamotrigine tablets. Modern analytical methods, such as HPLC-DAD, are essential to safety, effectiveness, and regulatory compliance