Validated capillary electrophoresis method for the simultaneous determination of piperidine and diethylamine in Entacapone drug substance using indirect UV detection

A rapid and sensitive capillary electrophoresis (CE) method was developed for the determination of piperidine and diethylamine content in Entacapone drug substance using a background electrolyte(solution containing 10 mM of imidazole buffer adjusted to pH 5.0 with 1 molar HCl) along with constant applied voltage of 25kV at ambient temperature(25°c). A 56cm fused silica capillary was used as a stationary phase. Indirect UV detection mode was employed for the determination of analyte signal at 240nm against the reference signal at 210nm and this method requires 8min for data acquisition. Linearity, precision and accuracy were performed in the range of 0.03-0.12% w/w respectively for piperidine and diethylamine. The method was validated with respect to specificity, linearity, accuracy, precision, ruggedness, robustness, and stability in analytical solution. The limit of quantification and detection for piperidine was 3.16 μg/ml and 1.01 μg/ml respectively while for diethylamine was 3.12 μg/ml and 0.99 μg /ml respectively

Author(s): Raja Gorla1,2 , B. Sreenivasulu1, N. Sreenivas1 and Raghu Babu Korupolu2

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