Sci. Pharm. 2011; 79: 277–291
A New Validated Liquid Chromatographic Method for the Determination of Loratadine and its Impurities
Gajjela RAMULU * 1,2, Yalavarthi RAVINDRA KUMAR 1, Krishnamurthy VYAS 1, Mulukutla V. SURYANARAYANA 1, Khagga MUKKANTI 2
1 Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500072, India.
2 Center for Pharmaceutical Sciences, IST, J. N. T. University, Kukatpally, Hyderabad-500072, A.P, India.
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 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.
Loratadine • Related impurities • Stability Indicating • RP-LC • Validation
Received December 12th, 2010 | Accepted February 10th, 2011 | Published Online February 12th, 2011