RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF BACLOFEN IN INJECTIONS
G. Sowjanya*, D. Gowri Sankar and J. V. L. N. Seshagiri Rao
ABSTRACT
A rapid, sensitive and economical RP-HPLC method has been
developed and validated for quantification of baclofen in injections. A
binary mixture of potassium dihydrogen phosphate, pentane 1-sulfonic
acid sodium salt buffer (pH 3.0) and a mixture of acetonitrile,
methanol in the optimized gradient mode was proved to be the most
suitable mobile phase for the separation of baclofen on a non-polar
Symmetry C18 column. The retention time for baclofen was at 5.538 ±
0.49 min. injected at a flow rate of 0.8 mL/min. and the detection wave
length was fixed at 225 nm. The method obeyed linearity in the range
of 0.0050 – 0.0150 mg/mL. The % RSD was found to be less than 2%
in intra-day (0.5) and inter-day (0.1) variation studies indicating that the method is precise.
The recovery of baclofen was found to be in the range of 98.6 - 100.5 % indicating that the
method is accurate. The method also tolerated minor variations in chromatographic
conditions indicating good robustness (% RSD < 1.0). The lowest values of LOD (4.46 × 10-5
mg/mL) and LOQ (1.35 × 10-4 mg/mL) as obtained by the proposed method indicate the
sensitivity of the method. The marketed injection was found to contain an average of 101.45
± 0.05 % w/v of baclofen as stated on the label claim and the excipients did not pose any
interference at the retention time of the drug indicating specificity of the method.
Experiments to study the effects of forced degradation on baclofen in injections were
conducted in the validation study as per ICH guidelines. This method can be used for the
regular quality control analysis of baclofen in API and injections.
Keywords: Baclofen, RP-HPLC, Gradient, Symmetry C18 column, Validation.
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