Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach
A UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing. The critical method parameters established were percent of o...
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| Format: | Article |
| Language: | English |
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Sciendo
2020-03-01
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| Series: | Acta Pharmaceutica |
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| Online Access: | https://doi.org/10.2478/acph-2020-0008 |
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| author | Saha Chandni Gupta N. Vishal Chandan R. S. |
| author_facet | Saha Chandni Gupta N. Vishal Chandan R. S. |
| author_sort | Saha Chandni |
| collection | DOAJ |
| description | A UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing. The critical method parameters established were percent of organic modifier, flow rate and injection volume. Optimization performed using Box-Behnken Design (BBD) established 10 % organic modifier, 0.4 mL min−1 flow rate and 6-µL injection volume as the optimum method conditions. Atazanavir sulfate eluted at 5.19 min without any interference. Method validation followed international guidelines. The method has proven linearity in the range of 10–90 µg mL−1. Recovery was between 100.2–101.0 % and precision within the accepted limits (RSD 0.2–0.7 %). LOD and LOQ were 2.68 and 8.14 µg mL−1, resp. Stress testing stability studies showed atazanavir sulfate to degrade under acidic and basic conditions. The suggested technique is simple, rapid and sustainable. It is, therefore, suggested for routine analysis of atazanavir sulfate. |
| format | Article |
| id | doaj-art-2654011b25ea461f841dc18493813499 |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2020-03-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-2654011b25ea461f841dc184938134992025-02-03T02:02:18ZengSciendoActa Pharmaceutica1846-95582020-03-01701173310.2478/acph-2020-0008acph-2020-0008Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approachSaha Chandni0Gupta N. Vishal1Chandan R. S.2Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru, Karnataka 570015IndiaDepartment of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru, Karnataka 570015IndiaDepartment of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru, Karnataka 570015IndiaA UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing. The critical method parameters established were percent of organic modifier, flow rate and injection volume. Optimization performed using Box-Behnken Design (BBD) established 10 % organic modifier, 0.4 mL min−1 flow rate and 6-µL injection volume as the optimum method conditions. Atazanavir sulfate eluted at 5.19 min without any interference. Method validation followed international guidelines. The method has proven linearity in the range of 10–90 µg mL−1. Recovery was between 100.2–101.0 % and precision within the accepted limits (RSD 0.2–0.7 %). LOD and LOQ were 2.68 and 8.14 µg mL−1, resp. Stress testing stability studies showed atazanavir sulfate to degrade under acidic and basic conditions. The suggested technique is simple, rapid and sustainable. It is, therefore, suggested for routine analysis of atazanavir sulfate.https://doi.org/10.2478/acph-2020-0008atazanavir sulfateuplc-ms“analytical quality by design” |
| spellingShingle | Saha Chandni Gupta N. Vishal Chandan R. S. Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach Acta Pharmaceutica atazanavir sulfate uplc-ms “analytical quality by design” |
| title | Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach |
| title_full | Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach |
| title_fullStr | Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach |
| title_full_unstemmed | Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach |
| title_short | Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach |
| title_sort | development and validation of a uplc ms method for determination of atazanavir sulfate by the analytical quality by design approach |
| topic | atazanavir sulfate uplc-ms “analytical quality by design” |
| url | https://doi.org/10.2478/acph-2020-0008 |
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