A simple, rapid, and sensitive RP-HPLC method was developed and validated for the simultaneous determination of degradation impurity of Noscapine HCl. The method was developed to determine Papaverine in Noscapine Hydrochloride. Separation was achieved within 45 minutes on a Waters Sunfire, C18, 250 x 4.6 mm, 5 μ particle size column using mobile phase consisting of 1-octane sulfonic acid buffer pH-3.0 and Acetonitrile. Gradient flow mode with a flow rate of 0.8 mL/min and detection was carried out at 260 nm. The column temperature was 45°C while sample temperature was 25°C. A complete validation procedure was carried out. There was good resolution observed between Noscapine and Papaverine Peak which is about 2.8. The proposed method exhibited excellent linearity over the concentration ranges of 1.2 μg/mL to 6.0 μg/mL for Papaverine and Noscapine. The proposed method was applied for bulk drug of Noscapine HCl for accuracy study with recovery of 101.26% to 104.52%.
