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Validation of an ultra‐fast UPLC‐UV method for the separation of antituberculosis tablets
Author(s) -
Nguyen Dao T.T.,
Guillarme Davy,
Rudaz Serge,
Veuthey JeanLuc
Publication year - 2008
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.200700537
Subject(s) - chromatography , pyrazinamide , high performance liquid chromatography , chemistry , gradient elution , rifampicin , isoniazid , elution , dosage form , analytical chemistry (journal) , tuberculosis , antibiotics , medicine , biochemistry , pathology
A simple method using ultra performance LC (UPLC) coupled with UV detection was developed and validated for the determination of antituberculosis drugs in combined dosage form, i. e. isoniazid (ISN), pyrazinamide (PYR) and rifampicin (RIF). Drugs were separated on a short column (2.1 mm×50 mm) packed with 1.7 μm particles, using an elution gradient procedure. At 30°C, less than 2 min was necessary for the complete separation of the three antituberculosis drugs, while the original USP method was performed in 15 min. Further improvements were obtained with the combination of UPLC and high temperature (up to 90°C), namely HT‐UPLC, which allows the application of higher mobile phase flow rates. Therefore, the separation of ISN, PYR and RIF was performed in less than 1 min. After validation (selectivity, trueness, precision and accuracy), both methods (UPLC and HT‐UPLC) have proven suitable for the routine quality control analysis of antituberculosis drugs in combined dosage form. Additionally, a large number of samples per day can be analysed due to the short analysis times.