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.
Highlights
PH increased to slightly 3.2 to 5.0 even though separation was not observed, again increased the pH to 6.9 separation was observed between Impurity-B and Impurity-A with 2.5 resolution but Impurity-E was merged with Loratadine
Established limit of detection (LOD) and limit of quantification (LOQ) for Impurity-A is 0.007% and 0.025% respectively in this method so it can useful for the determination and identification of this impurity
Sensitivity was determined by establishing the limit of detection (LOD) and limit of quantification (LOQ) for impurity-B, impurity-C, impurity-D and impurity-E estimated at a signal to noise ratio of 3:1 and 10:1 respectively, by injecting a series of dilute solutions with known concentration
Summary
Gajjela RAMULU * 1,2, Yalavarthi RAVINDRA KUMAR 1, Krishnamurthy VYAS 1, Mulukutla V. Published: Accepted: February 12th 2011 February 10th 2011 doi:10.3797/scipharm.1012-13. © Ramulu et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m.
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