Saeed Arayne M
Karachi-75270
Pakistan
Research Article
Monitoring of Pregabalin in Pharmaceutical Formulations and Human
Serum Using UV and RP-HPLC Techniques: Application to Dissolution
Test Method
Author(s): Saeed Arayne M, Hina Shahnaz, Amir Ali and Najma SultanaSaeed 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... View More»
DOI:
10.4172/2153-2435.1000287