Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms
The present work was the development of a simple, efficient, and reproducible stability-indicating reverse-phase high performance liquid chromatographic (RP-HPLC) method for simultaneous determination enrofloxacin (EFX) and its degradation products including ethylenediamine impurity, desfluoro impur...
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| Format: | Article |
| Language: | English |
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Wiley
2015-01-01
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| Series: | Journal of Analytical Methods in Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2015/735145 |
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| author | V. Ashok Chakravarthy B. B. V. Sailaja Avvaru Praveen Kumar |
| author_facet | V. Ashok Chakravarthy B. B. V. Sailaja Avvaru Praveen Kumar |
| author_sort | V. Ashok Chakravarthy |
| collection | DOAJ |
| description | The present work was the development of a simple, efficient, and reproducible stability-indicating reverse-phase high performance liquid chromatographic (RP-HPLC) method for simultaneous determination enrofloxacin (EFX) and its degradation products including ethylenediamine impurity, desfluoro impurity, ciprofloxacin impurity, chloro impurity, fluoroquinolonic acid impurity, and decarboxylated impurity in tablet dosage forms. The separation of EFX and its degradation products in tablets was carried out on Kromasil C-18 (250×4.6 mm, 5 μm) column using 0.1% (v/v) TEA in 10 mM KH2PO4 (pH 2.5) buffer and methanol by linear gradient program. Flow rate was 1.0 mL min−1 with a column temperature of 35°C and detection wavelength was carried out at 278 nm and 254 nm. The forced degradation studies were performed on EFX tablets under acidic, basic, oxidation, thermal, humidity, and photolytic conditions. The degraded products were well resolved from the main active drug and also from known impurities within 65 minutes. The method was validated in terms of specificity, linearity, LOD, LOQ, accuracy, precision, and robustness as per ICH guidelines. The results obtained from the validation experiments prove that the developed method is a stability-indicating method and suitable for routine analysis. |
| format | Article |
| id | doaj-art-820d14b9dd8f406c85a9ce37d8ee5011 |
| institution | Kabale University |
| issn | 2090-8865 2090-8873 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Analytical Methods in Chemistry |
| spelling | doaj-art-820d14b9dd8f406c85a9ce37d8ee50112025-02-03T01:26:18ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732015-01-01201510.1155/2015/735145735145Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage FormsV. Ashok Chakravarthy0B. B. V. Sailaja1Avvaru Praveen Kumar2Department of Inorganic and Analytical Chemistry, Andhra University, Visakhapatnam 530003, IndiaDepartment of Inorganic and Analytical Chemistry, Andhra University, Visakhapatnam 530003, IndiaDepartment of Chemistry, Changwon National University, Changwon 641-773, Republic of KoreaThe present work was the development of a simple, efficient, and reproducible stability-indicating reverse-phase high performance liquid chromatographic (RP-HPLC) method for simultaneous determination enrofloxacin (EFX) and its degradation products including ethylenediamine impurity, desfluoro impurity, ciprofloxacin impurity, chloro impurity, fluoroquinolonic acid impurity, and decarboxylated impurity in tablet dosage forms. The separation of EFX and its degradation products in tablets was carried out on Kromasil C-18 (250×4.6 mm, 5 μm) column using 0.1% (v/v) TEA in 10 mM KH2PO4 (pH 2.5) buffer and methanol by linear gradient program. Flow rate was 1.0 mL min−1 with a column temperature of 35°C and detection wavelength was carried out at 278 nm and 254 nm. The forced degradation studies were performed on EFX tablets under acidic, basic, oxidation, thermal, humidity, and photolytic conditions. The degraded products were well resolved from the main active drug and also from known impurities within 65 minutes. The method was validated in terms of specificity, linearity, LOD, LOQ, accuracy, precision, and robustness as per ICH guidelines. The results obtained from the validation experiments prove that the developed method is a stability-indicating method and suitable for routine analysis.http://dx.doi.org/10.1155/2015/735145 |
| spellingShingle | V. Ashok Chakravarthy B. B. V. Sailaja Avvaru Praveen Kumar Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms Journal of Analytical Methods in Chemistry |
| title | Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms |
| title_full | Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms |
| title_fullStr | Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms |
| title_full_unstemmed | Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms |
| title_short | Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Enrofloxacin and Its Degradation Products in Tablet Dosage Forms |
| title_sort | stability indicating rp hplc method for simultaneous estimation of enrofloxacin and its degradation products in tablet dosage forms |
| url | http://dx.doi.org/10.1155/2015/735145 |
| work_keys_str_mv | AT vashokchakravarthy stabilityindicatingrphplcmethodforsimultaneousestimationofenrofloxacinanditsdegradationproductsintabletdosageforms AT bbvsailaja stabilityindicatingrphplcmethodforsimultaneousestimationofenrofloxacinanditsdegradationproductsintabletdosageforms AT avvarupraveenkumar stabilityindicatingrphplcmethodforsimultaneousestimationofenrofloxacinanditsdegradationproductsintabletdosageforms |