ABSTRACT:
The objective of the present work was to develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and UV-spectrophotometric method and to validate the methods as per ICH guidelines for the quantitative estimation of loratadine. The optimized method employed a C18 ODS column (150×4.6mm, 5µm), a mobile phase of 35:45:20 (v/v) mixture of acetonitrile, methanol and a phosphate buffer solution (0.01M, pH 7.2±0.1), flow rate of 1.0 mL/min and a detection wavelength of 245nm (UV detector). A simple, sensitive and reliable UV-spectrophotometric method has also been developed. The proposed methods of loratadine in methanol were found to be precise with retention time (RT) at 3.59 min (0.295% RSD) and absorption maxima at 247.0 nm (0.072% RSD). The optimized methods of loratadine in 0.1 N HCl (dissolution media) was also found to be precise with RT of 3.60 min and absorption maxima at 280.0 nm. Results of the linearity studies were statistically validated and accuracy was established by drug recovery within the acceptable limits of 98-102%. The limits of detection and quantitation were determined for both the analytical systems. These validated methods were employed for the determination of loratadine release from lipidic formulations and the model independent similarity approach was used to compare the dissolution profiles. The results obtained by either of these methods equally resulted in efficient estimation of drug. However, spectrophotometric method can also present a reliable and reasonably accurate alternative for the determination of loratadine in pharmaceutical formulations.