Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC
A novel quantitative analytical method for the determination of Penicillin contaminant, Amoxicillin in non-penicillin pharmaceutical drug product (Ibuprofen tablet 400 mg) has been developed and validated using Ultra performance liquid chromatography (UPLC). The extraction of amoxicillin from the dr...
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| Format: | Article |
| Sprog: | English |
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Elsevier
2016
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| Online adgang: | http://psasir.upm.edu.my/id/eprint/53716/1/Quantitative%20measurement%20of%20amoxicillin%20in%20Ibuprofen%20tablets%20using%20UPLC.pdf |
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| author | Eid, Mohamed A. Yusof, Nor Azah Faruq, Mohammad Abdullah, Jaafar Sulaiman, Yusran |
| author_facet | Eid, Mohamed A. Yusof, Nor Azah Faruq, Mohammad Abdullah, Jaafar Sulaiman, Yusran |
| author_sort | Eid, Mohamed A. |
| collection | UPM |
| description | A novel quantitative analytical method for the determination of Penicillin contaminant, Amoxicillin in non-penicillin pharmaceutical drug product (Ibuprofen tablet 400 mg) has been developed and validated using Ultra performance liquid chromatography (UPLC). The extraction of amoxicillin from the drug tablets was carried out with bi-distilled water and the separation was achieved by making use of a BEH C18 column with particle size of 1.7 μm (100 mm × 2.1 mm). The isocratic run accomplished using phosphate buffer (pH 5.0): methanol (95:5, v/v) mixture as mobile phase run at a flow rate of 0.3 mL/min. The rapid, accurate and low cost UPLC method was proven to be suitable within the current good manufacturing practices (cGMP) of pharmaceutical ingredients. In addition, the validation of the developed method was conducted as per the ICH (International conference of harmonization) guidelines Q2 (R1). Further, the method was found to be linear in the range of (0.024–0.096 μg/mL for amoxicillin) with a correlation coefficient, R2 of 0.999 and net in terms of specificity, linearity, precision, accuracy, detection limit (DL), and quantitation limit (QL) are appeared to be satisfactory. The precision was assessed in terms of injections repeatability with a maximum %RSD of 1.8%, while the intermediate precision Day-1 with %RSD of 0.96 and the intermediate precision Day-2 with %RSD of 1.56 were observed. Thus, from the observation of satisfactory results for amoxicillin detection, the developed UPLC-based method can successfully be applied in the pharmaceutical quality control laboratories to fulfill the regulatory requirements. |
| first_indexed | 2024-03-06T09:18:39Z |
| format | Article |
| id | upm.eprints-53716 |
| institution | Universiti Putra Malaysia |
| language | English |
| last_indexed | 2024-03-06T09:18:39Z |
| publishDate | 2016 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | upm.eprints-537162018-01-10T08:14:16Z http://psasir.upm.edu.my/id/eprint/53716/ Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC Eid, Mohamed A. Yusof, Nor Azah Faruq, Mohammad Abdullah, Jaafar Sulaiman, Yusran A novel quantitative analytical method for the determination of Penicillin contaminant, Amoxicillin in non-penicillin pharmaceutical drug product (Ibuprofen tablet 400 mg) has been developed and validated using Ultra performance liquid chromatography (UPLC). The extraction of amoxicillin from the drug tablets was carried out with bi-distilled water and the separation was achieved by making use of a BEH C18 column with particle size of 1.7 μm (100 mm × 2.1 mm). The isocratic run accomplished using phosphate buffer (pH 5.0): methanol (95:5, v/v) mixture as mobile phase run at a flow rate of 0.3 mL/min. The rapid, accurate and low cost UPLC method was proven to be suitable within the current good manufacturing practices (cGMP) of pharmaceutical ingredients. In addition, the validation of the developed method was conducted as per the ICH (International conference of harmonization) guidelines Q2 (R1). Further, the method was found to be linear in the range of (0.024–0.096 μg/mL for amoxicillin) with a correlation coefficient, R2 of 0.999 and net in terms of specificity, linearity, precision, accuracy, detection limit (DL), and quantitation limit (QL) are appeared to be satisfactory. The precision was assessed in terms of injections repeatability with a maximum %RSD of 1.8%, while the intermediate precision Day-1 with %RSD of 0.96 and the intermediate precision Day-2 with %RSD of 1.56 were observed. Thus, from the observation of satisfactory results for amoxicillin detection, the developed UPLC-based method can successfully be applied in the pharmaceutical quality control laboratories to fulfill the regulatory requirements. Elsevier 2016-11 Article PeerReviewed application/pdf en http://psasir.upm.edu.my/id/eprint/53716/1/Quantitative%20measurement%20of%20amoxicillin%20in%20Ibuprofen%20tablets%20using%20UPLC.pdf Eid, Mohamed A. and Yusof, Nor Azah and Faruq, Mohammad and Abdullah, Jaafar and Sulaiman, Yusran (2016) Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC. Measurement, 93. pp. 465-472. ISSN 0263-2241; ESSN: 1873-412X https://www.sciencedirect.com/science/article/pii/S0263224116303980 10.1016/j.measurement.2016.07.039 |
| spellingShingle | Eid, Mohamed A. Yusof, Nor Azah Faruq, Mohammad Abdullah, Jaafar Sulaiman, Yusran Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC |
| title | Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC |
| title_full | Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC |
| title_fullStr | Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC |
| title_full_unstemmed | Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC |
| title_short | Quantitative measurement of amoxicillin in Ibuprofen tablets using UPLC |
| title_sort | quantitative measurement of amoxicillin in ibuprofen tablets using uplc |
| url | http://psasir.upm.edu.my/id/eprint/53716/1/Quantitative%20measurement%20of%20amoxicillin%20in%20Ibuprofen%20tablets%20using%20UPLC.pdf |
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