Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
47, Number 7, August 2009, pp. 549-552
An Improved Ion Chromatographic Method for Fast
and Sensitive Determination of N-Methylpyrrolidine in
Cefepime Hydrochloride
Narayanan Harihara Subramanian1, Shanmugam
Thyagarajan1,
Parthasarathy Manigandan1, R. Ganesh Jeevan2, and
Ganga Radhakrishnan2
1Metrohm India Limited, Application Lab;
2Central Leather Research
Institute, Expertise Centre for Eco testing Lab (EXCEL)
An alternative ion chromatographic method to the
existing USP method for the determination of N-methylpyrrolidine
(NMP) in cefepime hydrochloride is developed. The cefepime in
solution behaves as a strong cation and gets retained in the
analytical column, leading to reduction in column capacity and
irreproducible retention time. The retained drug has to be removed
with a special rinsing solution, followed by re-equilibration
with the mobile phase. This process takes at least 3 to 4 h time
for sample analysis. We used a silica-based cation exchange column
with poly-butadiene-maleic acid functional group attached with
an optimized mobile phase composition. The characteristic feature
of this method is the short analysis time with a clear separation
of NMP and the cationic drug molecule within a run-time of 30
min. The developed method overcomes the limitations of the USP
method. This method describes the matrix elimination by choosing
appropriate column and eluent condition. The method is tested
for selectivity, linearity, limits of detection and quantification,
accuracy, and precision and is suitable for continuous sample
analysis.
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