{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T15:19:34Z","timestamp":1787066374792,"version":"build-2736575974"},"reference-count":49,"publisher":"MDPI AG","issue":"22","license":[{"start":{"date-parts":[[2022,11,16]],"date-time":"2022-11-16T00:00:00Z","timestamp":1668556800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"King Saud University, Riyadh, Saudi Arabia","award":["RSP-2021\/371"],"award-info":[{"award-number":["RSP-2021\/371"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>Cross contamination of \u03b2-lactams is one of the highest risks for patients using pharmaceutical products. Penicillin and some non-penicillin \u03b2-lactams may cause potentially life-threatening allergic reactions. The trace detection of \u03b2-lactam antibiotics in cleaning rinse solutions of common reactors and manufacturing aids in pharmaceutical facilities is very crucial. Therefore, the common facilities adopt sophisticated cleaning procedures and develop analytical methods to assess traces of these compounds in rinsed solutions. For this, a highly sensitive and reproducible ultra-performance liquid chromatography with triple quadrupole mass spectrometry (UHPLC-MS\/MS) method was developed for the analysis of Cephapirin and Ceftiofur. As per the FDA guidelines described in FDA-2011-D-0104, the contamination of these \u03b2-lactam antibiotics must be regulated. The analysis was performed on an XBridge C18 column with 100 mm length, 4.6 mm diameter, and 3.5 \u00b5m particle size at an oven temperature of about 40 \u00b0C. The mobile phase was composed of 0.15% formic acid in water and acetonitrile as mobile phases A and B, and a flow rate was set to 0.6 mL\/min. The method was validated for Cephapirin and Ceftiofur. The quantification precision and accuracy were determined to be the lowest limit of detection 0.15 parts per billion (ppb) and the lowest limit of quantification 0.4 ppb. This method was linear in the range of 0.4 to 1.5 ppb with the determination of coefficient (R2 &gt; 0.99). This sensitive and fast method was fit-for-purpose for detecting and quantifying trace amounts of \u03b2-lactam contamination, monitoring cross contamination in facility surface cleaning, and determining the acceptable level of limits for regulatory purposes.<\/jats:p>","DOI":"10.3390\/molecules27227920","type":"journal-article","created":{"date-parts":[[2022,11,17]],"date-time":"2022-11-17T06:19:01Z","timestamp":1668665941000},"page":"7920","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Development and Validation for Quantification of Cephapirin and Ceftiofur by Ultraperformance Liquid Chromatography with Triple Quadrupole Mass Spectrometry"],"prefix":"10.3390","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3778-4991","authenticated-orcid":false,"given":"Hari Naga Prasada Reddy","family":"Chittireddy","sequence":"first","affiliation":[{"name":"Department of Engineering Chemistry, College of Engineering, Koneru Lakshmaiah Education Foundation, Vaddeswaram, Guntur 522 502, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. V. Shanmukha","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Engineering Chemistry, College of Engineering, Koneru Lakshmaiah Education Foundation, Vaddeswaram, Guntur 522 502, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anuradha","family":"Bhimireddy","sequence":"additional","affiliation":[{"name":"Aurobindo Pharma Limited, Sanga Reddy, Indrakaran 502329, Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2937-317X","authenticated-orcid":false,"given":"Mohammed Rafi","family":"Shaik","sequence":"additional","affiliation":[{"name":"Department of Chemistry, College of Science, King Saud University, P.O. Box 2455, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6389-9146","authenticated-orcid":false,"given":"Althaf Hussain","family":"Shaik","sequence":"additional","affiliation":[{"name":"Department of Zoology, College of Science, King Saud University, P.O. Box 2454, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7354-2693","authenticated-orcid":false,"given":"Abdulrahman","family":"Alwarthan","sequence":"additional","affiliation":[{"name":"Department of Chemistry, College of Science, King Saud University, P.O. Box 2455, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baji","family":"Shaik","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering, Yeungnam University, Gyeongsan 38541, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,11,16]]},"reference":[{"key":"ref_1","first-page":"288","article-title":"The requirements for manufacturing highly active or sensitising drugs comparing Good Manufacturing Practices","volume":"90","author":"Fabio","year":"2019","journal-title":"Acta Biomed. Ateneo Parm."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"a025247","DOI":"10.1101\/cshperspect.a025247","article-title":"\u03b2-Lactams and \u03b2-lactamase inhibitors: An overview","volume":"6","author":"Bush","year":"2016","journal-title":"Cold Spring Harb. Perspect. 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