Open AccessA NEW VALIDATED STABILITY-INDICATING DIRECT HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF ROSIGLITAZONE ENANTIOMERS IN THE PRESENCE OF ITS DEGRADATION PRODUCTS
Author(s) -
Gowramma Byran,
S. N. Meyyanathan,
B. Suresh Babu,
Krishnaveni Nagappan
Publication year - 2019
Publication title -
asian journal of pharmaceutical and clinical research
Language(s) - English
Resource type - Journals
eISSN - 2455-3891
pISSN - 0974-2441
DOI - 10.22159/ajpcr.2019.v12i3.24960
Subject(s) - chromatography , diethylamine , enantiomer , chemistry , detection limit , methanol , reproducibility , resolution (logic) , degradation (telecommunications) , high performance liquid chromatography , organic chemistry , telecommunications , artificial intelligence , computer science
Objective: In the present study, an isocratic chiral reverse-phase high-performance liquid chromatography method was developed and the resolution of the drug and complete separation from its degradation products were successfully achieved.
Methods: An isocratic method developed with a Phenomenex Lux 5 μ Cellulose 1 (150 mm×4.6 mm i.d., 5 μ) using UV detector at wavelength of 220 nm, with a mobile phase consisting of methanol:0.1% diethylamine (60:40% v/v) and a flow rate of 1 ml/min. The drug was subjected to alkaline, acidic, neutral, oxidative, and photolytic to apply stress conditions. The stressed samples were analyzed by the proposed method.
Results: The described method was linear over the range of 3–7 μg/ml for R-enantiomer and 9–21 μg/ml of S-enantiomer, respectively. The limit of detection and limit of quantification of R and S enantiomers were found to be 0.56 μg/ml and 0.18 μg/ml, respectively.
Conclusion: The method provides good sensitivity and excellent precision and reproducibility. The developed method can be applied in the quality control of drug products.