"Development and Validation of an Isocratic Reverse-Phase High-Performance Liquid Chromatographic Method for the Simultaneous Determination of Desloratadine and Montelukast sodium in Bulk Drug, Pharmaceutical Dosage Forms, and Human Plasma.”
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Abstract
This research article presents a straightforward, viable, and sensitive isocratic reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous determination of Desloratadine and Montelukast sodium in bulk drug, pharmaceutical dosage forms, and human plasma. The chromatographic analysis was performed on an Agilent C18 column (250 mm length x 4.6 mm ID, 5μm particle size), employing a mobile phase composed of a methanol and o-phosphoric acid (0.1% in water) mixture in a ratio of 75:25% v/v. The flow rate was set at 0.7 ml/min, and detection was conducted at 260 nm using an Agilent 1100 instrument equipped with an auto sampler, quaternary gradient pump (G-1314), and diode-array detector (DAD). Linearity was observed in concentration ranges of 5-25 μg/ml and 10-50 μg/ml for Desloratadine and Montelukast sodium, respectively. The regression equations for Desloratadine and Montelukast sodium were Y=58.18x-4.414 and Y=81.64x+1.394, respectively, with correlation coefficients of 0.9988 and 0.9992.The percentage recovery was determined to be 96.70% for Desloratadine and 100.21% for Montelukast sodium. The limits of detection (LOD) for Desloratadine and Montelukast sodium were found to be 0.14318 and 0.113935, respectively, while the limits of quantification (LOQ) were determined as 0.433879 and 0.345258, respectively. Both drugs exhibited a regression value of 0.999. Desloratadine demonstrated high susceptibility to basic degradation and low susceptibility to hydrolytic degradation, while Montelukast sodium was susceptible to basic conditions. The relative standard deviation for intra-day precision of Desloratadine and Montelukast sodium was 0.25% and 0.14%, respectively, and for inter-day precision, it was found to be 0.25% and 0.28%, respectively.