Add time:09/25/2019         Source:sciencedirect.com

As requested by regulatory authorities, impurity profiling is an important issue of quality control. In this work, a simple and sensitive liquid chromatographic (LC) method compatible with mass spectrometry (MS) was developed to study related substances and degradation products in Sodium cromoglycate (cas 15826-37-6) drug substance and eye drops. The method used a Sunfire column (4.6 mm × 150 mm, 3.5 μm). Mobile phase A consisted of 10 mM ammonium formate and mobile phase B was acetonitrile. Linear gradient elution with a post-run time of 8 min was performed as follows: 0–30 min, 3% B to 50% B; 30–35 min, 50% B. The flow rate was set at 1.0 mL/min. Degradation experiments were performed to check the stability indicating properties of the developed method. Based on MSn spectral data and exact mass measurements, the chemical structures of 2 unknown impurities and 6 unknown degradation products were characterized, including impurity C listed in the European Pharmacopoeia as unknown structure. In addition, a plausible mechanism for the formation of the degradation products was also proposed.

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