Open AccessDetermination and validation of pregabalin in bulk and pharmaceutical formulations by reversed phase-high performance liquid chromatography
Author(s) -
D. N. Vidya,
R Chaithra,
Gannu Praveen Kumar,
D. R. Bhadresh
Publication year - 2020
Publication title -
international journal of advanced chemistry
Language(s) - English
Resource type - Journals
ISSN - 2310-2977
DOI - 10.14419/ijac.v8i1.30513
Subject(s) - chromatography , detection limit , linearity , elution , high performance liquid chromatography , chemistry , volumetric flow rate , accuracy and precision , pharmaceutical formulation , methanol , detector , materials science , analytical chemistry (journal) , computer science , mathematics , physics , statistics , organic chemistry , quantum mechanics , telecommunications
A simple, specific, quick, isocratic Reversed Phase High Performance Liquid Chromatographic method was developed and validated for the analysis of Pregabalin in bulk and 5-different pharmaceutical formulations, the separation was accomplished on a C18, 5μm Reverse Phase column (250 mm × 4.6 mm) using a methanol : water (95:5, v/v) mobile phase. The compound was eluted isocratically at a flow rate of 0.8 ml /min. The UV detector was set at 288 nm for the detection of Pregabalin (PRG). The method was linear over the range of 5-45 μg/ml and validated with respect to accuracy, precision, linearity, and specificity, limit of detection and limit of quantization. Robustness testing was also conducted to evaluate the effect of minor changes to the chromatographic system and to establish appropriate system suitability parameters. This method was used successfully for the quality assessment of 5-different pharmaceutical formulations with good precision and accuracy.