Development and validation of dissolution method for levocetirizine dihydrochloride by isocratic reverse phase HPLC

Levocetirizine hydrochloride is an orally active, non-sedative antihistamine used in the symptomatic relief of seasonal and perennial allergic rhinitis. The main objective of the proposed study is to develop and validate a dissolution method of Levocetirizine hydrochloride dosage form by reverse phase HPLC isocratic method. The method is optimized by various filteration methods such as centrifuge and whatman 42. The filteration methods are evaluated by reverse phase isocratic HPLC method using columnPhenomenex Luna C 18 (250 mm x 4.6 mm; 5 μ), mobile phase – mixture of buffer and acetonitrile (580:420), adjusted pH to 6.0 with 10 % sodium hydroxide. buffer 4.08 g Potassium dihydrogen orthophosphate in 600 mL of water. The flow rate is 1.0 mL/min and the elutant is monitored at 230 nm with UV detector. The retention time of levocetirizine hydrochloride is 5.5. Precision shows that % relative standard deviation is about 1.1%. The percentage recovery of the levocetirizine from the dosage formulation is 99.6%. The results obtained for robustness and ruggedness of levocetirizine hydrochloride are well within the acceptance criteria. The proposed method is found to be simple, rapid, accurate and precise. The proposed methods are validated as per ICH guidelines and successfully applied for the determination of Levocetirizine tablet.