DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ASSAY OF PREGABALIN CAPSULE
Vaishali*,Vikas Singh, Rajnish Kumar Singh, Ramesh Kumar Gupta, Sudhansu
Ranjan Swain, Jagannath Sahoo
ABSTRACT
Background: Pregabalin is S-3-(amino methyl)-5-methylhexanoic
acid. It is an anticonvulsant drug for neuropathic pain and adjunct for
partial seizures. It can be used in generalised anxiety disorders.1,2
Methylcobalamin (MC;carbanide; cobalt; [5-5, 6-dimethyl
benzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl) oxolan-3-yl] 1-[3-
[2,13,18-tris (2-amino-2- oxoethyl)- 7,12,17- tris(3-amino- 3-
oxopropyl)-3,5,8,8,13,15,18,19-octamethy-2,7,12,17 tetrahydrocorrin-
3-yl]-propanoylamino]propan-2-yl hydrogen phosphate. It is a form of
Vit-B. Information collected from previous research has played an
important role to develop for quantitative estimation of pregabalin
from capsule dosage form.
Aim: The present study focused to developand validate the RP-HPLC
method for the assay of pregabalin capsule.
Methods: The method was validated according to ICH guidelines with respect to specificity,
linearity, accuracy, precision and robustness. The chromatography was set on Hypersil
BDS,C18 column (250mm×4.6mm, 5μ) column using fluorescence detector set at Ex 220nm
and Em 280nm. The mobile phase consisting of Water and Methanol in the ratio of 90:10 was
used.Result: The mobile phase consisting of Water and Methanol in the ratio of 90:10 which gave
better resolution and sensitivity with flow rate of 1 ml/min at temperature 40°C.The retention
time of Pregabalin was 6.4min .The method was found to be linear in the range of 14000-
26000 mcg/ml for pregabalin. Lower limit of quantification is 0.5 mg/l.
Conclusion:A simple, precise, specific, accurate highly selective reverse phase high
performance liquid chromatographic (RP-HPLC) method has been developed for the
determination of pregabalin in capsule dosage form.There is no generally accepted method
for the determination of pregabalin.This method was used successfully for the quality
assessment of pregabalin capsules with good precision and low cost. The pregabalin sample
solution was found to be stable at room temperature for about 24 h.
Keywords: Pregabalin capsule, RP-HPLC, Method development and validation.
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