Stability Indicating Liquid Chromatographic Method for the Estimation of Oxolamine Citrate in a Pharmaceutical Formulation

A stability indicating HPLC method for the estimation of oxolamine citrate in tablets was developed and validated. Oxolamine citrate is a cough suppressant. The HPLC method was performed with a reversed phase Zodiac C18 column (250 mm X 4.6 mm id, 5mm particle size), detection at 245 nm and a mixture of methanol, water and Acetonitrile as mobile phase. Typical retention time for oxolamine citrate was 7.25 min. Forced degradation studies were carried out. The drug was found to be stable to the dry heat, photo-degradation, oxidation, basic, and acidic condition attempted which indicate drug is highly stable. Quantification was achieved with ultraviolet detection at 245 nm over the concentration range 15 –90μg/ml with range of recovery 98.9 – 100.3 % for oxolamine citrate by the RP-HPLC method. The method was statistically validated for linearity, accuracy, precision and selectivity following ICH recommendations. Due to its simplicity and accuracy, the method can be used for routine quality control analysis.