title: A new validated liquid chromatographic method for the determination of loratadine and its impurities.
abstract: 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.
authors.affiliation: Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500072, India.
authors.forename: Gajjela
authors.initials: G
authors.lastname: Ramulu
authors.forename: Yalavarthi
authors.initials: Y
authors.lastname: Ravindra Kumar
authors.forename: Krishnamurthy
authors.initials: K
authors.lastname: Vyas
authors.forename: Mulukutla V
authors.initials: MV
authors.lastname: Suryanarayana
authors.forename: Khagga
authors.initials: K
authors.lastname: Mukkanti