A Validated Chiral HPLC Method for the Enantiomeric separation of Mefloquine

• Published in: Research journal of pharmacy and technology Vol. 12; no. 5; pp. 2304 - 2308
• Main Authors: Ashwini, S. Jenifer, Narenderan, S. T., Meyyanathan, S. N., Babu, B., Gowramma, B.
• Format: Journal Article
• Language: English
• Published: Raipur A&V Publications 01.05.2019
• Subjects: Chromatography; International conferences; Ions; Pharmaceutical industry; Pharmacy
• ISSN: 0974-3618; 0974-360X; 0974-306X
• DOI: 10.5958/0974-360X.2019.00384.6

The regulatory requirements are becoming tougher and enantiomeric purity of 99.9% is deemed necessary by the regulatory authorities like Food and Drug Administration (FDA) and International Conference on Harmonization (ICH)1.Chirality now plays a major role in the development of new pharmaceuticals which is driven by both regulatory and therapeutic rationales, one-third of all marketed drugs are now sold in single isomeric form2. LOD = 3.3 SD/s SD is the standard deviation of intercept s is the slope of the calibration curve Limit of Quantification (LOQ): Limit of quantification is the lowest concentration of the analyte in a sample that can be estimated quantitatively by injecting a decreasing amount of drug with acceptable precision and accuracy under the stated experimental conditions of the method. The optimized conditions were finally selected based on the criteria of peak properties like resolution factor, peak asymmetry factor, column theoretical plate number, capacity factor, peak height and peak area respectively. Geditz MCK, Lindner W, Lammerhofer M, Heinkele G, Kerb R, Ramharter M, Schwab M, Hofmann U. Simultaneous quantification of mefloquine (+) - and (-) - enantiomers and the carboxy metabolite in dried blood spots by liquid chromatography/tandem mass spectrometry.