Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma
Purpose Intracameral phenylephrine 1.0%/ketorolac 0.3% (OMIDRIA®) is used during cataract surgery to prevent intraoperative miosis and reduce postoperative pain. Although studied in beagles, no human data exist showing the duration ketorolac remains in the eye postoperatively. A clinical trial measu...
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Taylor & Francis Group
2025-12-01
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| Series: | Future Science OA |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/20565623.2025.2476866 |
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| author | Prajita Pandey Brianna A. White Colin Goswell Neelanjan Bose Sara Butterworth Connell Nicolee Schulze Jim Nevelos Ana Najafi Ramin Najafi Ryan K. Cheu |
| author_facet | Prajita Pandey Brianna A. White Colin Goswell Neelanjan Bose Sara Butterworth Connell Nicolee Schulze Jim Nevelos Ana Najafi Ramin Najafi Ryan K. Cheu |
| author_sort | Prajita Pandey |
| collection | DOAJ |
| description | Purpose Intracameral phenylephrine 1.0%/ketorolac 0.3% (OMIDRIA®) is used during cataract surgery to prevent intraoperative miosis and reduce postoperative pain. Although studied in beagles, no human data exist showing the duration ketorolac remains in the eye postoperatively. A clinical trial measuring ketorolac concentrations in aqueous/vitreous samples necessitated the development of a validation process for acquiring these measurements. Due to limited human aqueous/vitreous humor sample availability, a bioanalytical method was developed and validated to quantify ketorolac levels using human plasma as a surrogate matrix.Methods The developed process involves extracting ketorolac and its internal standard (ketorolac-d5) from plasma as a surrogate for aqueous and vitreous humor using a protein precipitation sample preparation technique, followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis.Results The validated method can be successfully applied for quantitation of ketorolac over a concentration range of 2.5 ng/mL to 5000 ng/mL. The method met the acceptance criteria with respect to selectivity, specificity, precision, accuracy, linearity, dilution integrity, and stability.Conclusions The validated method can use plasma as a surrogate matrix for quantitation of ketorolac in aqueous and vitreous humor, thereby eliminating the need to procure human vitreous and aqueous samples for validation prior to initiation of a clinical trial. |
| format | Article |
| id | doaj-art-e048fad4b10244d29d9b1246953622c4 |
| institution | OA Journals |
| issn | 2056-5623 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Future Science OA |
| spelling | doaj-art-e048fad4b10244d29d9b1246953622c42025-08-20T02:07:19ZengTaylor & Francis GroupFuture Science OA2056-56232025-12-0111110.1080/20565623.2025.2476866Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasmaPrajita Pandey0Brianna A. White1Colin Goswell2Neelanjan Bose3Sara Butterworth Connell4Nicolee Schulze5Jim Nevelos6Ana Najafi7Ramin Najafi8Ryan K. Cheu9Emery Pharma, Alameda, CA, USAEmery Pharma, Alameda, CA, USAEmery Pharma, Alameda, CA, USAEmery Pharma, Alameda, CA, USARayner Group, Bellevue, WA, USARayner Group, Bellevue, WA, USARayner Group, Bellevue, WA, USAEmery Pharma, Alameda, CA, USAEmery Pharma, Alameda, CA, USAEmery Pharma, Alameda, CA, USAPurpose Intracameral phenylephrine 1.0%/ketorolac 0.3% (OMIDRIA®) is used during cataract surgery to prevent intraoperative miosis and reduce postoperative pain. Although studied in beagles, no human data exist showing the duration ketorolac remains in the eye postoperatively. A clinical trial measuring ketorolac concentrations in aqueous/vitreous samples necessitated the development of a validation process for acquiring these measurements. Due to limited human aqueous/vitreous humor sample availability, a bioanalytical method was developed and validated to quantify ketorolac levels using human plasma as a surrogate matrix.Methods The developed process involves extracting ketorolac and its internal standard (ketorolac-d5) from plasma as a surrogate for aqueous and vitreous humor using a protein precipitation sample preparation technique, followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis.Results The validated method can be successfully applied for quantitation of ketorolac over a concentration range of 2.5 ng/mL to 5000 ng/mL. The method met the acceptance criteria with respect to selectivity, specificity, precision, accuracy, linearity, dilution integrity, and stability.Conclusions The validated method can use plasma as a surrogate matrix for quantitation of ketorolac in aqueous and vitreous humor, thereby eliminating the need to procure human vitreous and aqueous samples for validation prior to initiation of a clinical trial.https://www.tandfonline.com/doi/10.1080/20565623.2025.2476866Surrogate matrixvalidation studyliquid chromatography-tandem mass spectrometryOMIDRIAphenylephrine/ketorolacketorolac |
| spellingShingle | Prajita Pandey Brianna A. White Colin Goswell Neelanjan Bose Sara Butterworth Connell Nicolee Schulze Jim Nevelos Ana Najafi Ramin Najafi Ryan K. Cheu Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma Future Science OA Surrogate matrix validation study liquid chromatography-tandem mass spectrometry OMIDRIA phenylephrine/ketorolac ketorolac |
| title | Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma |
| title_full | Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma |
| title_fullStr | Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma |
| title_full_unstemmed | Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma |
| title_short | Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma |
| title_sort | bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma |
| topic | Surrogate matrix validation study liquid chromatography-tandem mass spectrometry OMIDRIA phenylephrine/ketorolac ketorolac |
| url | https://www.tandfonline.com/doi/10.1080/20565623.2025.2476866 |
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