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An improved gradient, reversed-phase liquid chromatographic (RP-LC) method was developed and subsequently validated for the determination of Loratadine and its impurities/degradation products in pharmaceutical drug substance. Separation was achieved with Inertsil ODS-3V, 250 × 4.6 mm, 5μ column with gradient elution at a flow rate of 1.0 mL min(-1). UV detection was performed at 220 nm. The described method is linear over a range of LOQ (0.044, 0.088, 0.084, and 0.072 μg mL(-1) for impurity-B, impurity-C, impurity-D, and impurity-E respectively) to 1.2 μg mL(-1) (0.6 μg mL(-1) of the specification limit) for all the impurities and degradation products. The recovery of impurities were found to be in the range of 85-115 %. The method is simple, selective, and accurate for the quantification of impurities and degradation products of Loratadine in its bulk drug samples.

A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities