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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