| Loratadine is one of the antihistamine drug active ingredients that reduce the effects of natural chemical histamine in the body. Histamine is the source of allergy symptoms such as itching, watery eyes, sneezing, and runny nose. Loratadine is used to treat these allergy symptoms. Unlike other antihistamines, when Loratadine is taken at recommended doses, it does not penetrate into the brain and does not cause sedating effect.;Several methods have been reported for determination of Loratadine in pharmaceutical preparations including spectrophotometry, polarography, densitometry, capillary electrophoresis, gas chromatography and HPLC. The aim of this work was to develop a stability-indication high performance reversed-phase liquid chromatographic method for the quantitative determination of Loratadine and to validate the developed method.;The separation was achieved on Agilent Zorbax-C18 column (4.6x250nm, 5micro particle size) using a mobile phase consisting of 55% potassium phosphate monobasic solution buffered at pH 2.9 and 45 % acetonitrile. The flow rate was controlled at 1.0 mL/minute with the injection volume 15 microL and detection wavelength accomplished at 225 nm. The retention time for Loratadine was approximately 9.5 minutes.;The drug was exposed to different degradation conditions such as acid hydrolysis, base hydrolysis, hydrogen peroxide oxidation, heat and UV light. Separation of degradants from Loratadine peak was achieved. The developed method was validated based on the ICH and USP guidelines in respect of Specificity, Robustness, Linearity, Accuracy, Precision, Limit of Detection, and Limit of Quantification. |
