| Autor: |
Bhatale, Mohan, Kaliyaperumal, Neelakandan, Mannathusamy, Gopalakrishnan, Ramalingam, Gurunathan |
| Předmět: |
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| Zdroj: |
Oriental Journal of Chemistry; Apr2021, Vol. 37 Issue 2, p493-498, 6p |
| Abstrakt: |
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. KH2 PO4 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 hydrochloride 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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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