{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T15:53:53Z","timestamp":1760889233427,"version":"build-2065373602"},"reference-count":39,"publisher":"Wiley","issue":"18","license":[{"start":{"date-parts":[[2016,8,31]],"date-time":"2016-08-31T00:00:00Z","timestamp":1472601600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J of Separation Science"],"published-print":{"date-parts":[[2016,9]]},"abstract":"<jats:p>A novel ultra high performance liquid chromatography method development strategy was ameliorated by applying quality by design approach. The developed systematic approach was divided into five steps (i) Analytical Target Profile, (ii) Critical Quality Attributes, (iii) Risk Assessments of Critical parameters using design of experiments (screening and optimization phases), (iv) Generation of design space, and (v) Process Capability Analysis (Cp) for robustness study using Monte Carlo simulation. The complete quality\u2010by\u2010design\u2010based method development was made automated and expedited by employing sub\u20102 \u03bcm particles column with an ultra high performance liquid chromatography system. Successful chromatographic separation of the Coenzyme Q10 from its biotechnological process related impurities was achieved on a Waters Acquity phenyl hexyl (100 mm \u00d7 2.1 mm, 1.7 \u03bcm) column with gradient elution of 10 mM ammonium acetate buffer (pH 4.0) and a mixture of acetonitrile\/2\u2010propanol (1:1) as the mobile phase. Through this study, fast and organized method development workflow was developed and robustness of the method was also demonstrated. The method was validated for specificity, linearity, accuracy, precision, and robustness in compliance to the International Conference on Harmonization, Q2 (R1) guidelines. The impurities were identified by atmospheric pressure chemical ionization\u2010mass spectrometry technique. Further, the in silico toxicity of impurities was analyzed using TOPKAT and DEREK software.<\/jats:p>","DOI":"10.1002\/jssc.201501405","type":"journal-article","created":{"date-parts":[[2016,8,4]],"date-time":"2016-08-04T07:37:02Z","timestamp":1470296222000},"page":"3528-3535","source":"Crossref","is-referenced-by-count":2,"title":["Automated statistical experimental design approach for rapid separation of coenzyme Q10 and identification of its biotechnological process related impurities using UHPLC and UHPLC\u2013APCI\u2010MS"],"prefix":"10.1002","volume":"39","author":[{"given":"Murali V.N. Kumar","family":"Talluri","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education &amp; Research IDPL  R&amp;D Campus, Balanagar Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pradipbhai D.","family":"Kalariya","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education &amp; Research IDPL  R&amp;D Campus, Balanagar Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shireesha","family":"Dharavath","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education &amp; Research IDPL  R&amp;D Campus, Balanagar Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naeem","family":"Shaikh","sequence":"additional","affiliation":[{"name":"Department of Pharmacoinformatics National Institute of Pharmaceutical Education and Research (NIPER)  Sector\u201067, S.A.S (Mohali) Nagar Punjab India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prabha","family":"Garg","sequence":"additional","affiliation":[{"name":"Department of Pharmacoinformatics National Institute of Pharmaceutical Education and Research (NIPER)  Sector\u201067, S.A.S (Mohali) Nagar Punjab India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nageswara Rao","family":"Ramisetti","sequence":"additional","affiliation":[{"name":"Mass and Analytical Division Indian Institute of Chemical Technology  Tarnaka Hyderabad"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Srinivas","family":"Ragampeta","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education &amp; Research IDPL  R&amp;D Campus, Balanagar Hyderabad India"},{"name":"Mass and Analytical Division Indian Institute of Chemical Technology  Tarnaka Hyderabad"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,8,31]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/0925-4439(95)00028-3"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1096\/fasebj.14.1.87"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ejcn.1600880"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ejcn.1601464"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.freeradbiomed.2011.11.017"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/biof.164"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1021\/ol010263d"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1021\/ol051329y"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-94-007-5055-5_15"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731-7085(98)00003-X"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731-7085(97)00057-5"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2006.03.037"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/0021-9673(92)80289-7"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2009.01.101"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/47.2.256"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1006\/abio.2002.5653"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2012.05.009"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2007.10.055"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-61779-504-6_11"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2007.10.019"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2007.12.034"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.taap.2009.08.022"},{"key":"e_1_2_9_24_1","unstructured":"International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Topic Q8 (R2): Pharmaceutical Development ICH Geneva Switzerland2009."},{"key":"e_1_2_9_25_1","unstructured":"International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Topic Q9: Quality Risk Management ICH Geneva Switzerland2005."},{"key":"e_1_2_9_26_1","unstructured":"International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Topic Q10: Pharmaceutical Quality System ICH Geneva Switzerland2008."},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201301364"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10337-014-2739-0"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201500976"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201500468"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201401459"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201300544"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201500343"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201200375"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.201300081"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1025361621494"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/0027-5107(94)90125-2"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/0300-483X(95)03190-Q"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/jms.3640"},{"key":"e_1_2_9_40_1","unstructured":"ICH guideline Q2 (R1): Validation of Analytical Procedures: Text and Methodology International Conference on Harmonization IFPMA Geneva Switzerland.2005."}],"container-title":["Journal of Separation Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjssc.201501405","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjssc.201501405","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jssc.201501405","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jssc.201501405","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jssc.201501405","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T12:00:34Z","timestamp":1760875234000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/jssc.201501405"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,8,31]]},"references-count":39,"journal-issue":{"issue":"18","published-print":{"date-parts":[[2016,9]]}},"alternative-id":["10.1002\/jssc.201501405"],"URL":"https:\/\/doi.org\/10.1002\/jssc.201501405","archive":["Portico"],"relation":{},"ISSN":["1615-9306","1615-9314"],"issn-type":[{"type":"print","value":"1615-9306"},{"type":"electronic","value":"1615-9314"}],"subject":[],"published":{"date-parts":[[2016,8,31]]}}}