Ultra Performance Liquid Chromatographic Seperation And Quantification Of Baclofen And And Its Potential Impurities In A Injection Formulation
Journal Title: IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) - Year 2018, Vol 13, Issue 4
Abstract
This study explores theapplication ofreversed phaseliquid chromatography (UPLC) for the simultaneous quantification of Baclofen and its potential impurities in a pre-filled syringe. The separation of impurities from Baclofen was achieved on Acquity BEHC18 100 x 2.1,1.7 µm, using a simple inexpensive buffer (potassium phosphate, 0.01 M), a mixture of acetonitrile and methanol as the mobile phase. The mobile phase was pumped at a flow rate of 0.3 mL min-1 using a simple linear gradient elution mode. The sample components were detected by UV-VIS detector at 225 nm. The method can resolveBaclofen and Pharmacopeia (USP and Ph. Eur) impurities in a single chromatographic injection within 8 minutes of run time. The method is validated as per the current ICH guidelines for method Validation for parameters like Precision, Linearity, Accuracy, and Robustness.A linear correlation of 0.999 was achieved between the analytes concentration and detector response between LOQ to 150% of the target specifications. The method is linear, accurate and precise between LOQ and 150% of the target concentration.
Authors and Affiliations
Venkata Narasimha Rao G, Muralee Krishna, Ranjith Kumar Reddy, Ravi Kumar Bellam
Keywords
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- EP ID EP395503
- DOI 10.9790/3008-1304022938
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