QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form
A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separat...
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| Format: | Article |
| Language: | English |
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Elsevier
2020-08-01
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| Series: | Practical Laboratory Medicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352551719301477 |
| _version_ | 1817986531192733696 |
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| author | Ashok K. Palakurthi Thirupathi Dongala Lakshmi Narasimha R. Katakam |
| author_facet | Ashok K. Palakurthi Thirupathi Dongala Lakshmi Narasimha R. Katakam |
| author_sort | Ashok K. Palakurthi |
| collection | DOAJ |
| description | A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables. |
| first_indexed | 2024-04-14T00:10:27Z |
| format | Article |
| id | doaj.art-4467520aa98a4656a4cce79969190697 |
| institution | Directory Open Access Journal |
| issn | 2352-5517 |
| language | English |
| last_indexed | 2024-04-14T00:10:27Z |
| publishDate | 2020-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Practical Laboratory Medicine |
| spelling | doaj.art-4467520aa98a4656a4cce799691906972022-12-22T02:23:21ZengElsevierPractical Laboratory Medicine2352-55172020-08-0121e00169QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage formAshok K. Palakurthi0Thirupathi Dongala1Lakshmi Narasimha R. Katakam2Aurex Laboratories LLC, 10 Lake Dr, East Windsor, NJ, 08520, USA; Corresponding author.Aurex Laboratories LLC, 10 Lake Dr, East Windsor, NJ, 08520, USA; Corresponding author.Analytical Development, Saptalis Pharmaceuticals LLC, Hauppauge, NY, USA, 11788A simple reverse phase liquid chromatographic gradient method has been developed and validated for the simultaneous determination of specified & un-specified impurities of Telmisartan and Hydrochlorothiazide in combination oral solid dosage forms. The developed method is effective to separate a total of sixteen (16) peaks and quantify eleven (11) specified impurities of Telmisartan and three (3) specified impurities of Hydrochlorothiazide with a minimum chromatographic resolution of 2.5. The separation was acquired with Inertsil ODS-3V, 150 × 4.6 mm, 3.5 μm column at a flow rate of 1.0 mL min-1 with the mobile phase-A consists of 0.02 M potassium dihydrogen phosphate (pH of 3.5) and mobile phase-B consists of a mixture of Milli-Q water and acetonitrile (100: 900 v/v) respectively. The detection of impurities was carried out at 230 nm and column temperature was maintained at 40 °C. Further optimized chromatographic conditions were applied to design of experiments to find out the critical quality attributes and established the design space. The binary combination of drug product was subjected to the different stress conditions such as acid, base, oxidation, heat and photolysis as per the recommendations of international conference on harmonization (Q2). The degradation Product found in stress patterns are well separated among main analyte compounds. The method was validated to be specific, robust and rugged in terms of change of chromatographic, instrumental and technical variables.http://www.sciencedirect.com/science/article/pii/S2352551719301477Analytical quality by designDesign of experimentsTelmisartanHydrochlorothiazideSolid dosage formHPLC-UV |
| spellingShingle | Ashok K. Palakurthi Thirupathi Dongala Lakshmi Narasimha R. Katakam QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form Practical Laboratory Medicine Analytical quality by design Design of experiments Telmisartan Hydrochlorothiazide Solid dosage form HPLC-UV |
| title | QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form |
| title_full | QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form |
| title_fullStr | QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form |
| title_full_unstemmed | QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form |
| title_short | QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form |
| title_sort | qbd based development of hplc method for simultaneous quantification of telmisartan and hydrochlorothiazide impurities in tablets dosage form |
| topic | Analytical quality by design Design of experiments Telmisartan Hydrochlorothiazide Solid dosage form HPLC-UV |
| url | http://www.sciencedirect.com/science/article/pii/S2352551719301477 |
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