Abstract

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.