Determination of active pharmaceutical ingredient – chloropyramine in dragées
Chloropyramine is a first generation antihistamine drug approved in some Eastern European countries for the treatment of allergic conjunctivitis, allergic rhinitis, bronchial asthma, and other allergic conditions. Chloropyramine is known as a competitive reversible H1-receptor antagonist. By blocking the effects of histamine, the drug inhibits the vasodilatation, increased vascular permeability, and tissue oedema associated with histamine release in the tissue.
A simple gas chromatography method based on gas chromatography - mass detection technique (GC-MS) for the determination of chloropyramine active pharmaceutical ingredient (API) in dragėes was developed and validated. Chromatographic separation was achieved on a fused silica ZB-5 capillary column (30 m x 0.25 mm i.d. x 0.25 µm film thickness). Acquisition was performed in selected ion monitoring mode (SIM) with target ion (58 m/z) and reference ions (71 m/z, 125 m/z).The method was validated in respect system suitability, specificity, linearity, range accuracy and precision, limit of detection (LOD), limit of quantification (LOQ), specificity, robustness and stability. The advantages of this method include simple sample treatment, short elution time (less than 15 min) and short analysis time (less than 25 min). The proposed method could be applicable for routine analysis in pharmaceutical analytical laboratories.Keywords: Active pharmaceutical ingredient, chloropyramine, gas chromatography-mass detection, dragėes