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Monitoring of Pregabalin in Pharmaceutical Formulations and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method

Saeed Arayne M, Hina Shahnaz, Amir Ali and Najma Sultana

Pregabalin an antiepileptic was the first compound approved by FDA for treating chronic pain. A sensitive, efficient, economical, environmental friendly and isocratic liquid chromatographic method for the determination of pregabalin in bulk drug, pharmaceutical dosage forms and human serum has been developed and validated according to ICH guidelines. Chromatographic separation was performed on a KROMASIL® 100-5 C-18 column (250×4.6 i.d. mm) (5 μm particle size) as stationary phase with a UV detection at 210 nm using isocratic elution when buffer pH 7 and acetonitrile (96:4, v/v) were used as the mobile phase and the flow rate was 1 ml min-1 at ambient temperature,the retention time was 4.6 minutes.The method showed good linearity in the range 1-25 μg mL-1 with R2>0.999. The lower limit of detection (LLOD) and quantitation (LLOQ) were 10 ng mL-1 and 17 ng mL-1 and 0.04 and 0.12 ng mL-1 for drug and serum, respectively. Validation of the method showed good precision and accuracy for the proposed method. The newly developed method can be successfully applied for the determination of pregabalin in active pharmaceutical ingredients, pharmaceutical formulations, human serum and could be used in therapeutic drug monitoring and clinical laboratories without diode array detector and without interference of excipients or endogenous components of serum.