A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities
AbstractAn 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 x 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.
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RAMULU, G.; RAVINDRA KUMAR, Y.; VYAS, K.; SURYANARAYANA, M.V.; MUKKANTI, K. A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities. Sci. Pharm. 2011, 79, 277-292.
RAMULU G, RAVINDRA KUMAR Y, VYAS K, SURYANARAYANA MV, MUKKANTI K. A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities. Scientia Pharmaceutica. 2011; 79(2):277-292.Chicago/Turabian Style
RAMULU, Gajjela; RAVINDRA KUMAR, Yalavarthi; VYAS, Krishnamurthy; SURYANARAYANA, Mulukutla V.; MUKKANTI, Khagga. 2011. "A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities." Sci. Pharm. 79, no. 2: 277-292.