Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms
A rapid, precise, sensitive, economical, and validated high performance thin layer chromatographic method is developed for simultaneous quantification of olmesartan medoxomil and hydrochlorothiazide in combined tablet dosage form. The method used amlodipine as internal standard (IS). Chromatographic...
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| Format: | Article |
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Wiley
2013-01-01
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| Series: | Journal of Analytical Methods in Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2013/363741 |
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| author | Kaliappan Ilango Pushpangadhan S. Shiji Kumar |
| author_facet | Kaliappan Ilango Pushpangadhan S. Shiji Kumar |
| author_sort | Kaliappan Ilango |
| collection | DOAJ |
| description | A rapid, precise, sensitive, economical, and validated high performance thin layer
chromatographic method is developed for simultaneous quantification of olmesartan
medoxomil and hydrochlorothiazide in combined tablet dosage form. The method used
amlodipine as internal standard (IS). Chromatographic separations were achieved on silica
gel 60 F254 plates using toluene-methanol-ethyl acetate-acetone (2.5 : 1 : 0.5 : 2, v/v/v/v) as
mobile phase. Densitometric analysis was carried out in the reflectance mode at 258 nm.
Calibration curves were linear over a range of 80–480 ng/band for olmesartan medoxomil and
25–150 ng/band for hydrochlorothiazide. The detection and quantification limits were found
to be 18.12 and 56.35 ng/band for olmesartan medoxomil and 6.31 and 18.56 ng/band for
hydrochlorothiazide, respectively. Intra- and interassay precision provided relative standard
deviations lower than 2% for both analytes. Recovery from 99.60 to 101.22% for olmesartan
medoxomil and 98.30 to 99.32% for hydrochlorothiazide show good accuracy. Both the
drugs were also subjected to acid, alkali, oxidation, heat, and photodegradation studies. The
degradation products obtained were well resolved from pure drugs with significantly different
values. As the method could effectively separate the drugs from their degradation products, it
can be used for stability-indicating analysis. Validation of the method was carried out as per
international conference on harmonization (ICH) guidelines. |
| format | Article |
| id | doaj-art-f3a74eb37f884707ba5ffd7d92b0938c |
| institution | Kabale University |
| issn | 2090-8865 2090-8873 |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Analytical Methods in Chemistry |
| spelling | doaj-art-f3a74eb37f884707ba5ffd7d92b0938c2025-02-03T06:00:25ZengWileyJournal of Analytical Methods in Chemistry2090-88652090-88732013-01-01201310.1155/2013/363741363741Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage FormsKaliappan Ilango0Pushpangadhan S. Shiji Kumar1Department of Pharmaceutical Chemistry, SRM College of Pharmacy, SRM University, Kattankulathur, Kancheepuram, Tamil Nadu 603 203, IndiaDepartment of Pharmaceutical Chemistry, Jamia Salafiya Pharmacy College, Pulikkal, Malappuram, Kerala 673 637, IndiaA rapid, precise, sensitive, economical, and validated high performance thin layer chromatographic method is developed for simultaneous quantification of olmesartan medoxomil and hydrochlorothiazide in combined tablet dosage form. The method used amlodipine as internal standard (IS). Chromatographic separations were achieved on silica gel 60 F254 plates using toluene-methanol-ethyl acetate-acetone (2.5 : 1 : 0.5 : 2, v/v/v/v) as mobile phase. Densitometric analysis was carried out in the reflectance mode at 258 nm. Calibration curves were linear over a range of 80–480 ng/band for olmesartan medoxomil and 25–150 ng/band for hydrochlorothiazide. The detection and quantification limits were found to be 18.12 and 56.35 ng/band for olmesartan medoxomil and 6.31 and 18.56 ng/band for hydrochlorothiazide, respectively. Intra- and interassay precision provided relative standard deviations lower than 2% for both analytes. Recovery from 99.60 to 101.22% for olmesartan medoxomil and 98.30 to 99.32% for hydrochlorothiazide show good accuracy. Both the drugs were also subjected to acid, alkali, oxidation, heat, and photodegradation studies. The degradation products obtained were well resolved from pure drugs with significantly different values. As the method could effectively separate the drugs from their degradation products, it can be used for stability-indicating analysis. Validation of the method was carried out as per international conference on harmonization (ICH) guidelines.http://dx.doi.org/10.1155/2013/363741 |
| spellingShingle | Kaliappan Ilango Pushpangadhan S. Shiji Kumar Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms Journal of Analytical Methods in Chemistry |
| title | Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms |
| title_full | Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms |
| title_fullStr | Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms |
| title_full_unstemmed | Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms |
| title_short | Application of a Stability-Indicating HPTLC Method for Simultaneous Quantitative Determination of Olmesartan Medoxomil and Hydrochlorothiazide in Pharmaceutical Dosage Forms |
| title_sort | application of a stability indicating hptlc method for simultaneous quantitative determination of olmesartan medoxomil and hydrochlorothiazide in pharmaceutical dosage forms |
| url | http://dx.doi.org/10.1155/2013/363741 |
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