Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form
In this study an effective method was developed to assay erythromycin ethylsuccinate for an oral suspension dosage form. The chromatographic separation was achieved on an X-Terra™ C18 analytical column. A mixture of acetonitrile–ammonium dihydrogen phosphate buffer (0.025 mol L-1) (60:40, V/V) (pH 7...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2014-12-01
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| Series: | Arabian Journal of Chemistry |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1878535211000086 |
| _version_ | 1798044057747849216 |
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| author | Fahimeh Kamarei Farshid Movaghari Alireza Ghaffari Iman Soltani Bozchalooi Ali Zamani Ali Jabbari |
| author_facet | Fahimeh Kamarei Farshid Movaghari Alireza Ghaffari Iman Soltani Bozchalooi Ali Zamani Ali Jabbari |
| author_sort | Fahimeh Kamarei |
| collection | DOAJ |
| description | In this study an effective method was developed to assay erythromycin ethylsuccinate for an oral suspension dosage form. The chromatographic separation was achieved on an X-Terra™ C18 analytical column. A mixture of acetonitrile–ammonium dihydrogen phosphate buffer (0.025 mol L-1) (60:40, V/V) (pH 7.0) was used as the mobile phase, effluent flow rate monitored at 1.0 mL min−1, and UV detection at 205 nm. In forced degradation studies, the effects of acid, base, oxidation, UV light and temperature were investigated showing no interference in the peak of drug. The proposed method was validated in terms of specificity, linearity, robustness, precision and accuracy. The method was linear at concentrations ranging from 400 to 600 μg mL−1, precise (intra- and inter-day relative standard deviations <0.65), accurate (mean recovery; 99.5%). The impurities and degradation products of erythromycin ethylsuccinate were selectively determined with good resolution in both the raw material and the final suspension forms. The method could be useful for both routine analytical and quality control assays of erythromycin ethylsuccinate in commercial powder for an oral suspension dosage form and it could be a very powerful tool to investigate the chemical stability of erythromycin ethylsuccinate. |
| first_indexed | 2024-04-11T22:57:33Z |
| format | Article |
| id | doaj.art-9c08a13915f14053970fbbda12bd8982 |
| institution | Directory Open Access Journal |
| issn | 1878-5352 |
| language | English |
| last_indexed | 2024-04-11T22:57:33Z |
| publishDate | 2014-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Arabian Journal of Chemistry |
| spelling | doaj.art-9c08a13915f14053970fbbda12bd89822022-12-22T03:58:22ZengElsevierArabian Journal of Chemistry1878-53522014-12-01761079108510.1016/j.arabjc.2011.01.004Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage formFahimeh Kamarei0Farshid Movaghari1Alireza Ghaffari2Iman Soltani Bozchalooi3Ali Zamani4Ali Jabbari5Pharmaceutical R&D Department, Chemi Darou Industrial Co., Tehran, IranPharmaceutical R&D Department, Chemi Darou Industrial Co., Tehran, IranPharmaceutical R&D Department, Chemi Darou Industrial Co., Tehran, IranDepartment of Mechanical Engineering, Massachusetts Institute of Technology, 77 Massachusetts Ave., Cambridge, MA 02139, USAPharmaceutical R&D Department, Chemi Darou Industrial Co., Tehran, IranPharmaceutical R&D Department, Chemi Darou Industrial Co., Tehran, IranIn this study an effective method was developed to assay erythromycin ethylsuccinate for an oral suspension dosage form. The chromatographic separation was achieved on an X-Terra™ C18 analytical column. A mixture of acetonitrile–ammonium dihydrogen phosphate buffer (0.025 mol L-1) (60:40, V/V) (pH 7.0) was used as the mobile phase, effluent flow rate monitored at 1.0 mL min−1, and UV detection at 205 nm. In forced degradation studies, the effects of acid, base, oxidation, UV light and temperature were investigated showing no interference in the peak of drug. The proposed method was validated in terms of specificity, linearity, robustness, precision and accuracy. The method was linear at concentrations ranging from 400 to 600 μg mL−1, precise (intra- and inter-day relative standard deviations <0.65), accurate (mean recovery; 99.5%). The impurities and degradation products of erythromycin ethylsuccinate were selectively determined with good resolution in both the raw material and the final suspension forms. The method could be useful for both routine analytical and quality control assays of erythromycin ethylsuccinate in commercial powder for an oral suspension dosage form and it could be a very powerful tool to investigate the chemical stability of erythromycin ethylsuccinate.http://www.sciencedirect.com/science/article/pii/S1878535211000086Stability-indicatingErythromycin ethylsuccinateOral suspensionPharmaceutical formsHigh performance liquid chromatography |
| spellingShingle | Fahimeh Kamarei Farshid Movaghari Alireza Ghaffari Iman Soltani Bozchalooi Ali Zamani Ali Jabbari Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form Arabian Journal of Chemistry Stability-indicating Erythromycin ethylsuccinate Oral suspension Pharmaceutical forms High performance liquid chromatography |
| title | Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form |
| title_full | Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form |
| title_fullStr | Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form |
| title_full_unstemmed | Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form |
| title_short | Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form |
| title_sort | development of a stability indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form |
| topic | Stability-indicating Erythromycin ethylsuccinate Oral suspension Pharmaceutical forms High performance liquid chromatography |
| url | http://www.sciencedirect.com/science/article/pii/S1878535211000086 |
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