Development and Validation of Estimation of Genotoxic Impurity (Hydroxylamine Hydrochloride content) in Leflunomide by using RP-HPLC technique
| Autor: | Mohan Bhatale, Gurunathan Ramalingam, Gopalakrishnan Mannathusamy, Neelakandan Kaliyaperumal |
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| Rok vydání: | 2021 |
| Předmět: |
Chromatography
010405 organic chemistry Chemistry Ornamental horticulture Industrial chemistry 02 engineering and technology General Chemistry 021001 nanoscience & nanotechnology Hydroxylamine Hydrochloride 01 natural sciences Biochemistry 0104 chemical sciences Elsevier Biobase Impurity GEOBASE Drug Discovery medicine Environmental Chemistry 0210 nano-technology Material chemistry Leflunomide medicine.drug |
| Zdroj: | Oriental Journal of Chemistry. 37:493-498 |
| ISSN: | 2231-5039 0970-020X |
| Popis: | A simple, selective, linear having accuracy and specific of reverse phase high-performance liquid chromatographic (RP-HPLC) method for determination of Genotoxic impurity Hydroxylamine Hydrochloride of drug Leflunomide is reported.The separation and analysis were done on YMC Triart C18 (4.6 mm x 150 mm), having particle size 3.0 μm. KH2PO4 in 2000 mL of purified water and 2 mL triethylamine with pH 2.5 with phosphoric acid is mobile phase-A while acetonitrile is mobile Phase-B with gradient program. The elution achieved with 1.50 mL/min flow rate and using UV detection at 230 nm wavelength. Selected column oven temperature is 45°C and auto sampler 5°C respectively. In this method linearity and accuracy of Hydroxylamine HCl covered with specification limit of LOQ to 150 % (i.e.3 to 23 ppm). The observed correlation coefficient is 0.99965 and recovery in between 99.07 to 114.94. In method precision (ie.repeatability) and intermediate precision (IP) observed % RSD of six spiked test preparation is below 5.0 %. The standard and sample were stable for 3 days when stored at 2 to 8°C temperature. In robustness studies system suitability parameters ie tailing factor, theoretical plates and %RSD does not show significant changes. The present RP-HPLC method is selective, robust, linear, and precise for detection of Hydroxylamine HCl. |
| Databáze: | OpenAIRE |
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