A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations
DOI:
https://doi.org/10.1590/S1984-82502013000100019Keywords:
High performance liquid chromatography^i1^squalitative analy, High performance liquid chromatography^i1^smethod developm, Pantoprazole^i1^sforced degradatAbstract
A stability-indicating high-performance liquid chromatographic (HPLC) method was developed with short run time and validated for the assay of process related impurities of pantoprazole in bulk form. Resolution of drug, its potential impurities and degradation products were achieved on a Hypersil ODS column utilizing a gradient with 0.01 M phosphate buffer of pH 7 and acetonitrile as eluent, at the detection wavelength of 290 nm. Flow rate was set at 1 mL min-1. The procedure was found to be specific, linear (r=0.999), recovery (97.9-103%), LOD (0.043-0.047 µgmL-1), LOQ (0.13-0.14 µgmL-1) and robust. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations. Pantoprazole was found to degrade in acidic, oxidative and under photolytic stress conditions. The drug was stable to alkaline and dry heat conditions. This method has been successively applied to pharmaceutical formulation and no interference from the excipients was found.Downloads
Download data is not yet available.
Downloads
Published
2013-03-01
Issue
Section
Articles
License
All content of the journal, except where identified, is licensed under a Creative Commons attribution-type BY.
The on line journal has open and free access.
How to Cite
A validated stability indicating HPLC method for the determination of process-related impurities in pantoprazole bulk drug and formulations . (2013). Brazilian Journal of Pharmaceutical Sciences, 49(1), 175-184. https://doi.org/10.1590/S1984-82502013000100019