Abstract
A novel, sensitive and selective stability-indicating gradient reverse phase ultra performance liquid chromatographic method was developed and validated for the quantitative determination of desloratadine and sodium benzoate in pharmaceutical oral liquid formulation. The chromatographic separation was achieved on Acquity BEH C8 (100 mm × 2.1 mm) 1.7 μm column by using mobile phase containing a gradient mixture of solvent A (0.05 M KH2PO4 and 0.07 M triethylamine, pH 3.0) and B (50:25:25 v/v/v mixture of acetonitrile, methanol and water) at flow rate of 0.4 mL/min. Column temperature was maintained at 40°C and detection was carried out at a wavelength of 272 nm. The described method shows excellent linearity over a range of 0.254 μg/mL to 76.194 μg/mL for desloratadine and 1.006 μg/mL to 301.67 μg/mL for sodium benzoate. The correlation coefficient for desloratadine and sodium benzoate was more than 0.999. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from desloratadine and sodium benzoate. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.
Highlights
Desloratadine, 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (Fig. 1), is a peripheral histamine H1-receptor anatagonist commonly used to treat allergy symptoms such as nasal and nonnasal symptoms of seasonal allergic rhinits
An isocratic method was employed using 0.05 M potassium dihydrogen ortho-phosphate and acetonitrile in the ratio of 75:25 as mobile phase, Acquity BEH C18 (100 mm x 2.1 mm) 1.7 μm column with flow rate of 0.4 mL/min on ultra-performance liquid chromatography (UPLC) equipped with photo diode array detector
Sodium benzoate was resolved from placebo peaks but desloratadine peak eluted late along with degradation product
Summary
Desloratadine, 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (Fig. 1), is a peripheral histamine H1-receptor anatagonist commonly used to treat allergy symptoms such as nasal and nonnasal symptoms of seasonal allergic rhinits. These methods may not be suitable for simultaneous determination of desloratadine and sodium benzoate together in one chromatographic run. Attempts were made in this study to develop a fast, sensitive, selective and stability-indicating reverse phase ultra-performance liquid chromatography (UPLC) method for the simultaneous determination of desloratadine and sodium benzoate in oral liquid formulation.
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