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A novel validated LC method for quantitation of lopinavir in bulk drug and pharmaceutical formulation in the presence of its potential impurities and degradation products
Author(s) -
Seshachalam U.,
Haribabu B.,
Chandrasekhar KB
Publication year - 2007
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.810
Subject(s) - chemistry , chromatography , forced degradation , detection limit , lopinavir , impurity , pharmaceutical formulation , dosage form , methanol , hydrolysis , degradation (telecommunications) , analyte , calibration curve , organic chemistry , human immunodeficiency virus (hiv) , telecommunications , computer science , medicine , family medicine , antiretroviral therapy , viral load
A simple isocratic liquid chromatographic method was developed for determination of lopinavir from its related impurities and assay for the first time. This method involves the use of a C 8 (Symmetry Shield RP8, 150 × 4.6 mm, 5 µm) column. The method was validated over the range of limit of quantitation (LOQ) to 120% of impurity specification limit and LOQ to 150% of working concentration for assay. The mobile phase consisted of a mixture of 50 m m of potassium phosphate buffer, acetonitrile and methanol in the ratio of 40:50:10. The flow rate was set at 1.0 mL/min with UV detection monitored at 210 nm. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The developed method was validated for linearity, range, precision, accuracy and specificity. This method was successfully applied for content determination of lopinavir in pharmaceutical formulations. The method can be conveniently used in a quality control laboratory for routine analysis for assay and related substances as well for the evaluation of stability samples of bulk drugs and pharmaceutical formulations. Copyright © 2007 John Wiley & Sons, Ltd.