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| Content Provider | Springer Nature Link |
|---|---|
| Author | Lalitha Devi, M. Chandrasekhar, K. B. |
| Copyright Year | 2009 |
| Abstract | A validated, specific, stability-indicating reversed-phase liquid chromatographic method has been developed for quantitative analysis of moxifloxacin and its related substances in bulk samples and pharmaceutical dosage forms in the presence of degradation products and process-related impurities. Forced degradation studies were performed on bulk samples of moxifloxacin, in accordance with ICH guidelines, using acidic, basic, and oxidizing conditions, and thermal and photolytic stress, to show the stability-indicating power of the method. Significant degradation was caused by oxidative stress and by basic conditions; no degradation was observed under the other stress conditions. The method was optimized by analysis of the samples generated during the forced degradation studies and sample solutions spiked with the impurities. Good resolution between the analyte peak and peaks corresponding to process-related impurities and degradation products was achieved on a C18 column with a simple linear mobile phase gradient prepared from aqueous sodium dihydrogen orthophosphate dihydrate containing triethylamine, pH adjusted to 3.0 with orthophosphoric acid, and methanol. Detection was performed at 240 nm. Limits of detection and quantification were established for moxifloxacin and its process related impurities. When the stressed test solutions were assayed against moxifloxacin working standard solution the mass balance was always between 99.3 and 100.1%, indicating the method was stability-indicating. The method was validated in accordance with ICH guidelines, and found to be suitable for checking the quality of bulk samples of moxifloxacin at the time of release of a batch and during storage (long term and accelerated stability testing was conducted). |
| Starting Page | 993 |
| Ending Page | 999 |
| Page Count | 7 |
| File Format | |
| ISSN | 00095893 |
| Journal | Chromatographia |
| Volume Number | 69 |
| Issue Number | 9-10 |
| e-ISSN | 16121112 |
| Language | English |
| Publisher | Vieweg Verlag |
| Publisher Date | 2009-03-21 |
| Publisher Place | Wiesbaden |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Column liquid chromatography Forced degradation RSD and validation Moxifloxacin Measurement Science, Instrumentation Plant Sciences Biochemistry Pharmacy Organic Chemistry Analytical Chemistry |
| Content Type | Text |
| Resource Type | Article |
| Subject | Organic Chemistry Analytical Chemistry Biochemistry Clinical Biochemistry |
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