Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets
A methodology (HPLC) proposed in this paper for simultaneously quantitative determination of ilaprazole and its related impurities in commercial tablets was developed and validated. The chromatographic separation was carried out by gradient elution using an Agilent C8 column (4.6 mm × 250 mm, 5 μm)...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2015-04-01
|
| Series: | Asian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1818087614000695 |
| _version_ | 1818011246394343424 |
|---|---|
| author | Shang Wang Dong Zhang Yingli Wang Xiaohong Liu Yan Liu Lu Xu |
| author_facet | Shang Wang Dong Zhang Yingli Wang Xiaohong Liu Yan Liu Lu Xu |
| author_sort | Shang Wang |
| collection | DOAJ |
| description | A methodology (HPLC) proposed in this paper for simultaneously quantitative determination of ilaprazole and its related impurities in commercial tablets was developed and validated. The chromatographic separation was carried out by gradient elution using an Agilent C8 column (4.6 mm × 250 mm, 5 μm) which was maintained at 25 °C. The mobile phase composed of solvent A (methanol) and solvent B (solution consisting 0.02 mmol/l monopotassium phosphate and 0.025 mmol/l sodium hydroxide) was at a flow rate of 1.0 ml/min. The samples were detected and quantified at 237 nm using an ultraviolet absorbance detector. Calibration curves of all analytes from 0.5 to 3.5 μg/ml were good linearity (r ≥ 0.9990) and recovery was greater than 99.5% for each analyte. The lower limit of detection (LLOD) and quantification (LOQ) of this analytical method were 10 ng/ml and 25 ng/ml for all impurities, respectively. The stress studies indicated that the degradation products could not interfere with the detection of ilaprazole and its related impurities and the assay can thus be considered stability-indicating. The method precisions were in the range of 0.41–1.21 while the instrument precisions were in the range of 0.38–0.95 in terms of peak area RSD% for all impurities, respectively. This method is considered stability-indicating and is applicable for accurate and simultaneous measuring of the ilaprazole and its related impurities in commercial enteric-coated tablets. |
| first_indexed | 2024-04-14T06:05:17Z |
| format | Article |
| id | doaj.art-0da0a03eb8294da7b571c741976f0308 |
| institution | Directory Open Access Journal |
| issn | 1818-0876 |
| language | English |
| last_indexed | 2024-04-14T06:05:17Z |
| publishDate | 2015-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Asian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-0da0a03eb8294da7b571c741976f03082022-12-22T02:08:32ZengElsevierAsian Journal of Pharmaceutical Sciences1818-08762015-04-0110214615110.1016/j.ajps.2014.09.001Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tabletsShang WangDong ZhangYingli WangXiaohong LiuYan LiuLu XuA methodology (HPLC) proposed in this paper for simultaneously quantitative determination of ilaprazole and its related impurities in commercial tablets was developed and validated. The chromatographic separation was carried out by gradient elution using an Agilent C8 column (4.6 mm × 250 mm, 5 μm) which was maintained at 25 °C. The mobile phase composed of solvent A (methanol) and solvent B (solution consisting 0.02 mmol/l monopotassium phosphate and 0.025 mmol/l sodium hydroxide) was at a flow rate of 1.0 ml/min. The samples were detected and quantified at 237 nm using an ultraviolet absorbance detector. Calibration curves of all analytes from 0.5 to 3.5 μg/ml were good linearity (r ≥ 0.9990) and recovery was greater than 99.5% for each analyte. The lower limit of detection (LLOD) and quantification (LOQ) of this analytical method were 10 ng/ml and 25 ng/ml for all impurities, respectively. The stress studies indicated that the degradation products could not interfere with the detection of ilaprazole and its related impurities and the assay can thus be considered stability-indicating. The method precisions were in the range of 0.41–1.21 while the instrument precisions were in the range of 0.38–0.95 in terms of peak area RSD% for all impurities, respectively. This method is considered stability-indicating and is applicable for accurate and simultaneous measuring of the ilaprazole and its related impurities in commercial enteric-coated tablets.http://www.sciencedirect.com/science/article/pii/S1818087614000695IlaprazoleEnteric-coated tabletsRelated impuritiesHPLCValidation |
| spellingShingle | Shang Wang Dong Zhang Yingli Wang Xiaohong Liu Yan Liu Lu Xu Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets Asian Journal of Pharmaceutical Sciences Ilaprazole Enteric-coated tablets Related impurities HPLC Validation |
| title | Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets |
| title_full | Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets |
| title_fullStr | Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets |
| title_full_unstemmed | Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets |
| title_short | Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets |
| title_sort | gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets |
| topic | Ilaprazole Enteric-coated tablets Related impurities HPLC Validation |
| url | http://www.sciencedirect.com/science/article/pii/S1818087614000695 |
| work_keys_str_mv | AT shangwang gradienthighperformanceliquidchromatographymethodforsimultaneousdeterminationofilaprazoleanditsrelatedimpuritiesincommercialtablets AT dongzhang gradienthighperformanceliquidchromatographymethodforsimultaneousdeterminationofilaprazoleanditsrelatedimpuritiesincommercialtablets AT yingliwang gradienthighperformanceliquidchromatographymethodforsimultaneousdeterminationofilaprazoleanditsrelatedimpuritiesincommercialtablets AT xiaohongliu gradienthighperformanceliquidchromatographymethodforsimultaneousdeterminationofilaprazoleanditsrelatedimpuritiesincommercialtablets AT yanliu gradienthighperformanceliquidchromatographymethodforsimultaneousdeterminationofilaprazoleanditsrelatedimpuritiesincommercialtablets AT luxu gradienthighperformanceliquidchromatographymethodforsimultaneousdeterminationofilaprazoleanditsrelatedimpuritiesincommercialtablets |