Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in combination with process capability index
An ultra high performance liquid chromatography method was developed and validated for the quantitation of triamcinolone acetonide in an injectable ophthalmic hydrogel to determine the contribution of analytical method error in the content uniformity measurement. During the development phase, the de...
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| Veröffentlicht in: | Journal of separation science 2016-07, Vol.39 (14), p.2689-2701 |
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| container_issue | 14 |
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| container_title | Journal of separation science |
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| creator | Oliva, Alexis Monzón, Cecilia Santoveña, Ana Fariña, José B. Llabrés, Matías |
| description | An ultra high performance liquid chromatography method was developed and validated for the quantitation of triamcinolone acetonide in an injectable ophthalmic hydrogel to determine the contribution of analytical method error in the content uniformity measurement. During the development phase, the design of experiments/design space strategy was used. For this, the free R‐program was used as a commercial software alternative, a fast efficient tool for data analysis. The process capability index was used to find the permitted level of variation for each factor and to define the design space. All these aspects were analyzed and discussed under different experimental conditions by the Monte Carlo simulation method. Second, a pre‐study validation procedure was performed in accordance with the International Conference on Harmonization guidelines. The validated method was applied for the determination of uniformity of dosage units and the reasons for variability (inhomogeneity and the analytical method error) were analyzed based on the overall uncertainty. |
| doi_str_mv | 10.1002/jssc.201600273 |
| format | Article |
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During the development phase, the design of experiments/design space strategy was used. For this, the free R‐program was used as a commercial software alternative, a fast efficient tool for data analysis. The process capability index was used to find the permitted level of variation for each factor and to define the design space. All these aspects were analyzed and discussed under different experimental conditions by the Monte Carlo simulation method. Second, a pre‐study validation procedure was performed in accordance with the International Conference on Harmonization guidelines. 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Sep. Science</addtitle><description>An ultra high performance liquid chromatography method was developed and validated for the quantitation of triamcinolone acetonide in an injectable ophthalmic hydrogel to determine the contribution of analytical method error in the content uniformity measurement. During the development phase, the design of experiments/design space strategy was used. For this, the free R‐program was used as a commercial software alternative, a fast efficient tool for data analysis. The process capability index was used to find the permitted level of variation for each factor and to define the design space. All these aspects were analyzed and discussed under different experimental conditions by the Monte Carlo simulation method. Second, a pre‐study validation procedure was performed in accordance with the International Conference on Harmonization guidelines. The validated method was applied for the determination of uniformity of dosage units and the reasons for variability (inhomogeneity and the analytical method error) were analyzed based on the overall uncertainty.</description><subject>Chromatography</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Computer programs</subject><subject>Computer simulation</subject><subject>Content uniformity</subject><subject>Design analysis</subject><subject>Design of experiments</subject><subject>Design space</subject><subject>Error analysis</subject><subject>High performance liquid chromatography</subject><subject>Hydrogels</subject><subject>Hydrogels - chemistry</subject><subject>Mathematical analysis</subject><subject>Monte Carlo Method</subject><subject>Monte Carlo simulation</subject><subject>Strategy</subject><subject>Triamcinolone</subject><subject>Triamcinolone Acetonide - analysis</subject><subject>Ultra high performance liquid chromatography</subject><issn>1615-9306</issn><issn>1615-9314</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNks1u1DAUhSMEoqWwZYkssWEzre0kdrxELRSqqiwKFLGxHOcm8ZDYqe3QmYflXXCYYRasWPnvO-ce2zfLXhJ8SjCmZ-sQ9CnFhKUFzx9lx4SRciVyUjw-zDE7yp6FsMaY8Ergp9kR5aQqKOPH2a8L-AmDm0awEbkWKYvmIXqFetP1aALfOj8qqwEN5n42DdK9d6OKrvNq6rdohNi7BiUKNRDBj8Ya26HojRq1sW5wFpDSEJ01DSBjUb9tvOtgCGgOf9AekjSYzi71YZNqmiVNONvvhinpUUihInTbxUK7sTZWReMsejAx5fROQwhIq0nVZjBxwRrYPM-etGoI8GI_nmRf3r_7fP5hdf3p8uP52-uVLnLOVxXTlLQc64LxkjHOC5LnCiuqWi6UqGmrmqYkwASuMW8KBQyDaEVbFVVNOc5Psjc73xTkfoYQ5WiChmFQFtwcJKnysmRCYPEfKOa4orTkCX39D7p2s7fpIgvFCowZp4l6tafmeoRGTun5lN_Kv3-cgGIHPJgBtodzguXSQXLpIHnoIHl1e3teVGKRrXYyEyJsDjLlf8hkykt5d3Mpb-6-EvGdXMlv-W_Ntc4u</recordid><startdate>201607</startdate><enddate>201607</enddate><creator>Oliva, Alexis</creator><creator>Monzón, Cecilia</creator><creator>Santoveña, Ana</creator><creator>Fariña, José B.</creator><creator>Llabrés, Matías</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7U5</scope><scope>8FD</scope><scope>L7M</scope><scope>7X8</scope></search><sort><creationdate>201607</creationdate><title>Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in combination with process capability index</title><author>Oliva, Alexis ; 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Sep. Science</addtitle><date>2016-07</date><risdate>2016</risdate><volume>39</volume><issue>14</issue><spage>2689</spage><epage>2701</epage><pages>2689-2701</pages><issn>1615-9306</issn><eissn>1615-9314</eissn><abstract>An ultra high performance liquid chromatography method was developed and validated for the quantitation of triamcinolone acetonide in an injectable ophthalmic hydrogel to determine the contribution of analytical method error in the content uniformity measurement. During the development phase, the design of experiments/design space strategy was used. For this, the free R‐program was used as a commercial software alternative, a fast efficient tool for data analysis. The process capability index was used to find the permitted level of variation for each factor and to define the design space. All these aspects were analyzed and discussed under different experimental conditions by the Monte Carlo simulation method. Second, a pre‐study validation procedure was performed in accordance with the International Conference on Harmonization guidelines. The validated method was applied for the determination of uniformity of dosage units and the reasons for variability (inhomogeneity and the analytical method error) were analyzed based on the overall uncertainty.</abstract><cop>Germany</cop><pub>Blackwell Publishing Ltd</pub><pmid>27184267</pmid><doi>10.1002/jssc.201600273</doi><tpages>13</tpages></addata></record> |
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| ispartof | Journal of separation science, 2016-07, Vol.39 (14), p.2689-2701 |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | Chromatography Chromatography, High Pressure Liquid Computer programs Computer simulation Content uniformity Design analysis Design of experiments Design space Error analysis High performance liquid chromatography Hydrogels Hydrogels - chemistry Mathematical analysis Monte Carlo Method Monte Carlo simulation Strategy Triamcinolone Triamcinolone Acetonide - analysis Ultra high performance liquid chromatography |
| title | Development of an ultra high performance liquid chromatography method for determining triamcinolone acetonide in hydrogels using the design of experiments/design space strategy in combination with process capability index |
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