Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

An improved validated ultra high pressure liquid chromatography method for separation of Rotigotine impurities in Rotigotine Transdermal Patch

Author(s): *Avinash S. Patil , Shakil S. Sait, Girish Deshpande, Prakashkumar Acharya and Veeravenkata Srikanth Kaki

A rapid, specific, sensitive ultra high-performance liquid chromatographic (UPLC) method has been developed for determination of Rotigotine impurities and its degradation products in Rotigotine Transdermal Patches. UPLC was performed on a C18 column with “mobile phase A” consist of pH 10.00 buffer solution while “mobile phase B” consist of Acetonitrile. The mobile phase was pumped in a gradient manner at the flow-rate of 0.4 mL min−1. Ultraviolet detection was performed at 225 nm. Rotigotine impurities and degradation products along with process impurities were chromatographed with a total run time of 30 minutes. Calibration showed that response of impurities was a linear function of concentration over the range LOQ to 200% of the target concentration (r 2 ≥ 0.999) and the method was validated over this range for precision, accuracy, linearity and specificity. For precision study, percentage relative standard deviation of each impurity was <15% (n = 6). The method was found to be precise, accurate, linear and specific. The method was successfully employed for estimation of Rotigotine impurities and its degradation products in finished product formulation.


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