Der Pharmacia Lettre
Abstract
Author(s): Syeda Humaira ,Akalanka Dey, S. Appala Raju, Syed Sanaullah
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 50Ã?¢Ã?â?¬Ã?â??300Ã?ŽÃ?¼g mLÃ?¢Ã?â?¬Ã?â??1with a detection limit of 0.04 mg mLÃ?¢Ã?â?¬Ã?â??1
and a quantification limit of 0.16 mg mLÃ?¢Ã?â?¬Ã?â??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 mLÃ?¢Ã?â?¬Ã?â??1) were 0.02Ã?¢Ã?â?¬Ã?â??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 97.7Ã?¢Ã?â?¬Ã?â??103.2 with precision
in the range 1.6Ã?¢Ã?â?¬Ã?â??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.
