CHIRAL LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR SEPERATION OF PHENIRAMINE ENANTIOMERS

Pheniramine is an antihistamine with anticholinergic properties used to treat allergic conditions such as hay fever or urticaria. It has relatively strong sedative effects, and may sometimes be used off-label as an over-the-counter sleeping pill in a similar manner to other sedating antihistamines such as diphenhydramine. Pheniramine is also commonly found in eyedrops used for the treatment of allergic conjunctivitis. According to literature survey there is no method reported for the seperation of Pheniramine enantiomers by RP-HPLC in pharmaceutical dosage forms. This present research work mainly focus to develop and validate a new RP-HPLC method for separation of Pheniramine enantiomers in pharmaceutical dosage forms in accordance with the ICH guidelines. A new simple, precise and accurate HPLC method was developed and validated for the seperation of Pheniramine 1 and Pheniramine 2 in pharmaceutical dosage form. In this method, Chiral pack column (150x4.6, 5?m) was selected as the stationary phase. Water and acetonitrile were taken in the ratio 90:10%v/v and used as mobile phase at a flow rate of 1.0 ml/min. The retention times of Pheniramine 1 and Pheniramine 2 were found to be 6.6 min & 9.1 min respectively. Hence, the developed method can be successfully employed for enantiomeric separation of Pheniramine maleate in drug testing laboratories and pharmaceutical industries. Key words: Pheiramine maleate, Chiral column, RP-HPLC, Acetonitrile, Enantiomers