Gradient ultra fast liquid chromatographic analysis of Pramipexole and its application to drug quality control

By Syeda Humaira, Akalanka Dey, S. Appala Raju and Syed Sanaullah

ABSTRACT


A rapid, sensitive and selective method for the determination of Pramipexole in pure drug and in tablets was developed using gradient Ultra Fast Liquid Chromatography (UFLC). The devised method involved separation of Pramipexole (PRM) on a Reversed Phase Waters Symmetry Column and determination with UV detection at 260 nm. The standard curve was linear (R = 0.999) over the concentration range of 50–300µg mL–1with a detection limit of 0.04 mg mL–1 and a quantification limit of 0.16 mg mL–1. Intra-day and inter-day precision and accuracy of the method were established according to the current ICH guidelines. Intra-day and interlay of   RSD values at three QC levels (100, 150 and 200 mg mL–1) were 0.02–0.05%, based on the peak area. The intra-day relative error (er) was between 0.01 and 0.2%. The developed method was successfully applied to the determination of PRM in tablets and the results were statistically compared with those obtained by a literature method. Accuracy evaluated by means of the spike recovery method, was the excellent with percent recovery in the range 97.7–103.2 with precision in the range 1.6–2.2%. No interference was observed from the co-formulated substances. The method was economical in terms of the time taken and the amount of solvent used.

Keywords: Pramipexole, gradient UFLC, pharmaceuticals.

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