Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form
Described is a first reported, simple, rapid, selective, and isocratic stability-indicating RP-LC method for the quantitative determination of tapentadol and its related substances in bulk samples and pharmaceutical dosage forms in the presence of its two process-related impurities. Chromatographic...
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| Format: | Article |
| Language: | English |
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Wiley
2013-01-01
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| Series: | Journal of Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2013/927814 |
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| author | Singaram Kathirvel Suggala Venkata Satyanarayana Garikapati Devalarao |
| author_facet | Singaram Kathirvel Suggala Venkata Satyanarayana Garikapati Devalarao |
| author_sort | Singaram Kathirvel |
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| description | Described is a first reported, simple, rapid, selective, and isocratic stability-indicating RP-LC method for the quantitative determination of tapentadol and its related substances in bulk samples and pharmaceutical dosage forms in the presence of its two process-related impurities. Chromatographic separation was achieved on the reversed phase, Enable column (C18 (5-μm, 250 × 4.6 mm, i.d.)) at ambient temperature using a mobile phase consisting of 0.02 M potassium dihydrogen orthophosphate (adjusted to pH 6 with 1 M KOH) and acetonitrile (80 : 20, v/v). Flow rate was 1 mL/min and retention time was found to be 7.7 ± 0.05 min. Quantitation was achieved with UV detection at 215 nm based on peak area with linear calibration curves at concentration range 75–300 μg/mL. Forced degradation studies were performed, in accordance with ICH guidelines, using acidic, alkaline, oxidative, neutral, photolytic, and thermal conditions. The drug was found to be stable under all the conditions. The developed method was validated in terms of precision, robustness, recovery, and limits of detection and quantitation. Regression analysis shows an “r” value (correlation coefficient) of greater than 0.999 for tapentadol and two potential impurities. |
| format | Article |
| id | doaj-art-4a73b30262d545f6ab8b985187d47ea4 |
| institution | Kabale University |
| issn | 2090-9063 2090-9071 |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Chemistry |
| spelling | doaj-art-4a73b30262d545f6ab8b985187d47ea42025-02-03T05:47:32ZengWileyJournal of Chemistry2090-90632090-90712013-01-01201310.1155/2013/927814927814Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage FormSingaram Kathirvel0Suggala Venkata Satyanarayana1Garikapati Devalarao2Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur 522002, IndiaDepartment of Chemical Engineering, JNTUA College of Engineering, Anantapur 515002, IndiaKVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada 520008, IndiaDescribed is a first reported, simple, rapid, selective, and isocratic stability-indicating RP-LC method for the quantitative determination of tapentadol and its related substances in bulk samples and pharmaceutical dosage forms in the presence of its two process-related impurities. Chromatographic separation was achieved on the reversed phase, Enable column (C18 (5-μm, 250 × 4.6 mm, i.d.)) at ambient temperature using a mobile phase consisting of 0.02 M potassium dihydrogen orthophosphate (adjusted to pH 6 with 1 M KOH) and acetonitrile (80 : 20, v/v). Flow rate was 1 mL/min and retention time was found to be 7.7 ± 0.05 min. Quantitation was achieved with UV detection at 215 nm based on peak area with linear calibration curves at concentration range 75–300 μg/mL. Forced degradation studies were performed, in accordance with ICH guidelines, using acidic, alkaline, oxidative, neutral, photolytic, and thermal conditions. The drug was found to be stable under all the conditions. The developed method was validated in terms of precision, robustness, recovery, and limits of detection and quantitation. Regression analysis shows an “r” value (correlation coefficient) of greater than 0.999 for tapentadol and two potential impurities.http://dx.doi.org/10.1155/2013/927814 |
| spellingShingle | Singaram Kathirvel Suggala Venkata Satyanarayana Garikapati Devalarao Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form Journal of Chemistry |
| title | Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form |
| title_full | Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form |
| title_fullStr | Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form |
| title_full_unstemmed | Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form |
| title_short | Application of a Validated Stability-Indicating LC Method for the Simultaneous Estimation of Tapentadol and Its Process-Related Impurities in Bulk and Its Dosage Form |
| title_sort | application of a validated stability indicating lc method for the simultaneous estimation of tapentadol and its process related impurities in bulk and its dosage form |
| url | http://dx.doi.org/10.1155/2013/927814 |
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