Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage Form
Introduction. Etoricoxib is a selective cyclooxygenase (COX-2) inhibitor used for the treatment of acute pain and has anti-inflammatory and analgesic efficacy. Etoricoxib causes fewer complications compared to other non-steroidal anti-inflammatory drugs (NSAIDs). FSI "SID and GP" has devel...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2023-05-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/1488 |
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| author | A. Kh. Amandusova A. E. Kovalenko A. V. Morozov K. R. Savelyeva T. L. Batalova O. A. Ostapyuk L. V. Persanova T. Yu. Andreevicheva A. G. Beniashvili V. N. Shestakov S. V. Polyakov |
| author_facet | A. Kh. Amandusova A. E. Kovalenko A. V. Morozov K. R. Savelyeva T. L. Batalova O. A. Ostapyuk L. V. Persanova T. Yu. Andreevicheva A. G. Beniashvili V. N. Shestakov S. V. Polyakov |
| author_sort | A. Kh. Amandusova |
| collection | DOAJ |
| description | Introduction. Etoricoxib is a selective cyclooxygenase (COX-2) inhibitor used for the treatment of acute pain and has anti-inflammatory and analgesic efficacy. Etoricoxib causes fewer complications compared to other non-steroidal anti-inflammatory drugs (NSAIDs). FSI "SID and GP" has developed an ophthalmic liquid dosage form based on etoricoxib. This article proposes a method for determining the content of etoricoxib in a liquid dosage form by high performance liquid chromatography with UV detection.Aim. Development and validation of a method for the quantitative determination of etoricoxib in liquid dosage form.Materials and methods. Eye drops with a concentration of the active substance etoricoxib of 0.05 % were used for the analysis, a standard sample of etoricoxib (Kekule Pharma Limited, India, series ACE-3 WS001/15). Chromatographic separation performed on an Agilent 1220 Infinity II LC high performance liquid chromatograph (Agilent Technologies, USA) equipped with a gradient pump, a column thermostat, and a diode array detector. The analysis carried out on a Kromasil C8 column 250 × 4.6 mm, using acetonitrile and 0.05 M buffer solution of potassium dihydrogen phosphate pH = 4.2 as a mobile phase in a ratio of 46 : 54. The analysis time was 15 minutes at a detection wavelength of 235 nm.Results and discussion. A method for the quantitative determination of etoricoxib in a liquid dosage form developed and validated according to the following indicators: specificity, linearity, accuracy, range, intermediate precision, repeatability.Conclusion. According to the results of validation tests, all of the listed parameters meet the acceptance criteria. The proposed method characterize by high efficiency and specificity. |
| format | Article |
| id | doaj-art-2ad4e1e393d04558be52a584df229d31 |
| institution | Kabale University |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2023-05-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-2ad4e1e393d04558be52a584df229d312025-08-20T03:39:45ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492023-05-011229510210.33380/2305-2066-2023-12-2-95-1021102Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage FormA. Kh. Amandusova0A. E. Kovalenko1A. V. Morozov2K. R. Savelyeva3T. L. Batalova4O. A. Ostapyuk5L. V. Persanova6T. Yu. Andreevicheva7A. G. Beniashvili8V. N. Shestakov9S. V. Polyakov10Federal State Institution «State Institute of Drugs and Good Practices»; Mendeleev University of Chemical Technology of RussiaMendeleev University of Chemical Technology of RussiaFederal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Federal State Institution «State Institute of Drugs and Good Practices»Introduction. Etoricoxib is a selective cyclooxygenase (COX-2) inhibitor used for the treatment of acute pain and has anti-inflammatory and analgesic efficacy. Etoricoxib causes fewer complications compared to other non-steroidal anti-inflammatory drugs (NSAIDs). FSI "SID and GP" has developed an ophthalmic liquid dosage form based on etoricoxib. This article proposes a method for determining the content of etoricoxib in a liquid dosage form by high performance liquid chromatography with UV detection.Aim. Development and validation of a method for the quantitative determination of etoricoxib in liquid dosage form.Materials and methods. Eye drops with a concentration of the active substance etoricoxib of 0.05 % were used for the analysis, a standard sample of etoricoxib (Kekule Pharma Limited, India, series ACE-3 WS001/15). Chromatographic separation performed on an Agilent 1220 Infinity II LC high performance liquid chromatograph (Agilent Technologies, USA) equipped with a gradient pump, a column thermostat, and a diode array detector. The analysis carried out on a Kromasil C8 column 250 × 4.6 mm, using acetonitrile and 0.05 M buffer solution of potassium dihydrogen phosphate pH = 4.2 as a mobile phase in a ratio of 46 : 54. The analysis time was 15 minutes at a detection wavelength of 235 nm.Results and discussion. A method for the quantitative determination of etoricoxib in a liquid dosage form developed and validated according to the following indicators: specificity, linearity, accuracy, range, intermediate precision, repeatability.Conclusion. According to the results of validation tests, all of the listed parameters meet the acceptance criteria. The proposed method characterize by high efficiency and specificity.https://www.pharmjournal.ru/jour/article/view/1488etoricoxibliquid dosage formhigh performance liquid chromatography (hplc)validation |
| spellingShingle | A. Kh. Amandusova A. E. Kovalenko A. V. Morozov K. R. Savelyeva T. L. Batalova O. A. Ostapyuk L. V. Persanova T. Yu. Andreevicheva A. G. Beniashvili V. N. Shestakov S. V. Polyakov Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage Form Разработка и регистрация лекарственных средств etoricoxib liquid dosage form high performance liquid chromatography (hplc) validation |
| title | Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage Form |
| title_full | Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage Form |
| title_fullStr | Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage Form |
| title_full_unstemmed | Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage Form |
| title_short | Development and Validation of a Method for the Quantitative Determination of Etoricoxib in Liquid Dosage Form |
| title_sort | development and validation of a method for the quantitative determination of etoricoxib in liquid dosage form |
| topic | etoricoxib liquid dosage form high performance liquid chromatography (hplc) validation |
| url | https://www.pharmjournal.ru/jour/article/view/1488 |
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