Development and Validation of a HPLC Method for Chlorphenamine Maleate Related Substances in Multicomponents Syrups and Tablets

Chlorphenamine maleate is a first-generation alkylamine antihistamine used in the prevention of the symptoms of allergic conditions such as rhinitis and urticaria. Because of that it is frequently used in multicomponents pharmaceutical formulations against the cold. Since the method for determination chlorphenamine related substances in pharmaceutical products is not described in current pharmacopoeias, the aim of this work was to develop and validate a precise, accurate and robust method. HPLC method for determination related substances of chlorphenamine maleate has several problems, how to separate all active ingridients and their impurity in this formulation. Also, problem was to separate placebo in syrup because of presented flavor. Separation was achieved on a reversed-phase C-18 column (5 μm, 25 cm x 0.46 cm, kept at 30°C), using a mixture of potassium dihydrogen phosphate and octane sulphonate sodium salt in water and acetonitrile as mobile phase, at flow rate 1.0 ml/min and UV detection at 214 nm. The method was validated following ICH guidelines and validation parameters showed that it could be used as stability indicating method for determination of related substances of chlorphenamine maleate in multicomponents syrups and tablets.