A Novel Stability Indicating Reverse Phase Ultra Performance Liquid Chromatography Method Development and Validation for Estimation of Related Compounds of Parecoxib Sodium in Parecoxib Sodium for Injection.
Journal Title: IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) - Year 2017, Vol 12, Issue 4
Abstract
A new and rapid stability-indicatingreversed-phase ultra performance liquid chromatography (UPLC) method was developed and validated for determination of Parecoxibimpurities in Injectionformulation. The chromatographic separation was carried out on an Acquity UPLC BEH C18, (100mmx2.1mm) 1.7µmusing a mobile phase consisting of Potassium dihydrogen phosphate buffer with pH 6.5, acetonitrile and methanol using gradient programme at a flow rate of 0.30 ml/min with an injection volume of 2µL andthe UV detection was performed at 240 nm. The method was validated for precision, accuracy, specificity, linearity, sensitivity and robustness. The proposed method can be applied for quality control, release and stability analysis of Parecoxib impurities in Injection formulation.
Authors and Affiliations
Dhananjay P. Dwivedi, B. Ravi Kumar, Sridhar. Y, Prof. J. Sreeramlu1
Keywords
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- EP ID EP390358
- DOI 10.9790/3008-1204075867
- Views 81
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