{"id":57,"date":"2024-04-04T00:39:48","date_gmt":"2024-04-03T21:39:48","guid":{"rendered":"https:\/\/sisu.ut.ee\/lcms_method_validation\/10-ruggedness-robustness\/"},"modified":"2024-06-20T09:54:59","modified_gmt":"2024-06-20T06:54:59","slug":"10-ruggedness-robustness","status":"publish","type":"page","link":"https:\/\/sisu.ut.ee\/lcms_method_validation\/10-ruggedness-robustness\/","title":{"rendered":"10. Ruggedness, robustness"},"content":{"rendered":"<p>In this part of the course, the robustness and ruggedness are introduced and explained.<\/p>\n<p>The terms robustness and ruggedness refer to the ability of an analytical method to remain unaffected by small variations in the method parameters (mobile phase composition, column age, column temperature, etc.) and influential environmental factors (room temperature, air humidity, etc.) and characterize its reliability during normal usage.<\/p>\n<p>The notion of remaining unaffected by varying a method parameter has two possible interpretations \u2013 it can be interpreted as:<\/p>\n<ul>\n<li>(a) no change of the detected amount of the analyte in a certain sample despite of the variation of the method parameter or\u00a0<\/li>\n<li>(b) no change of the critical performance characteristics (e.g. limit of quantitation) by the variation of the method parameter.<\/li>\n<\/ul>\n<p>In experimental evaluation of robustness either one of these interpretations can be used.<\/p>\n<p>Robustness and ruggedness definitions in the guidelines as well as review articles are very similar. Some guidelines use the term robustness and some use ruggedness. When used together these terms\u00a0are treated as synonyms in most cases.\u00a0<\/p>\n<h5 style=\"text-align: center;\"><div class=\"ratio ratio-16x9 mb-3\"><div class=\"video-placeholder-wrapper video-placeholder-wrapper--16x9\">\n\t\t\t    <div class=\"video-placeholder d-flex justify-content-center align-items-center\">\n\t\t\t        <div class=\"overlay text-white p-2 w-100 text-center d-block justify-content-center align-items-center\">\n\t\t\t            <div>To view third-party content, please accept cookies.<\/div>\n\t\t\t            <button class=\"btn btn-secondary btn-sm mt-1 consent-change\">Change consent<\/button>\n\t\t\t        <\/div>\n\t\t\t    <\/div>\n\t\t\t<\/div>\n<\/div><\/h5>\n<h5 style=\"text-align: center;\">Robustness and ruggedness introduction<\/h5>\n<h5 style=\"text-align: center;\"><a href=\"http:\/\/www.uttv.ee\/naita?id=23686\" target=\"_blank\" rel=\"noopener\">http:\/\/www.uttv.ee\/naita?id=23686<\/a><\/h5>\n<h5 style=\"text-align: center;\"><a href=\"https:\/\/www.youtube.com\/watch?v=8Fpo71pUTR4&amp;feature=youtu.be\" target=\"_blank\" rel=\"noopener\">https:\/\/www.youtube.com\/watch?v=8Fpo71pUTR4&amp;feature=youtu.be<\/a><\/h5>\n<p>These definitions refer to changes made to the method <strong>within the same laboratory.<\/strong> However, robustness can also be described as the feasibility to reproduce the analytical method in different laboratories or under different circumstances without the occurrence of unexpected differences in the obtained results or performance parameters.<\/p>\n<p>Along the similar lines it has been suggested that <strong>ruggedness<\/strong> should be used as a parameter evaluating constancy of the results when external factors such as analyst, laboratory, instrument, reagents and days are varied and\u00a0<strong>robustness<\/strong> should be used as a parameter characterizing the stability of the method with respect to variations of the internal factors of the method. This involves the parameters related to sample preparation, mobile phase composition, mobile phase flow rate, injection volume, column temperature etc. In addition, an important aspect of the robustness is the stability of the method against the variability of the\u00a0sample matrix.<\/p>\n<p>There are studies where the terms robustness\/ruggedness are misinterpreted and actually decision threshold, detection capability or measurement uncertainty is evaluated.<\/p>\n<p>In this course we use the term <strong>robustness<\/strong> for expressing the <strong>stability of the method against small variations of the intrinsic method parameters<\/strong> (<a href=\"https:\/\/sisu.ut.ee\/lcms_method_validation\/101-robustness-and-ruggedness-relation-lc-ms-method-development\" target=\"_blank\" rel=\"noopener\">section 10.1<\/a>) <strong>and variability of sample matrix <\/strong>(<a href=\"https:\/\/sisu.ut.ee\/lcms_method_validation\/102-matrix-robustness\" target=\"_blank\" rel=\"noopener\">section 10.2<\/a>).\u00a0<\/p>\n<p>In this course we use the term <strong>ruggedness <\/strong>for <strong>expressing the stability of the method against extraneous influencing factors<\/strong>.<\/p>\n<p>We address changes of the method parameters (i.e. within-laboratory assessment of robustness) and the variability of the sample matrices. We do not explicitly address changes occurring when a method is transferred from one laboratory to another.<\/p>\n\n\n<div class=\"wp-block-group attached-files-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-c64b8705-793f-45b0-bac4-92fc39fcc6f7\" href=\"https:\/\/sisu.ut.ee\/wp-content\/uploads\/sites\/130\/10_robustness_ruggedness_introduction.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">10_robustness_ruggedness_introduction.pdf<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In this part of the course, the robustness and ruggedness are introduced and explained. The terms robustness and ruggedness refer to the ability of an analytical method to remain unaffected by small variations in the method parameters (mobile phase composition, &#8230;<\/p>\n","protected":false},"author":60,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-57","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages\/57","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/users\/60"}],"replies":[{"embeddable":true,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/comments?post=57"}],"version-history":[{"count":3,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages\/57\/revisions"}],"predecessor-version":[{"id":1391,"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/pages\/57\/revisions\/1391"}],"wp:attachment":[{"href":"https:\/\/sisu.ut.ee\/lcms_method_validation\/wp-json\/wp\/v2\/media?parent=57"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}