RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination
Introduction: Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodi...
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| Format: | Article |
| Language: | English |
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Pensoft Publishers
2022-02-01
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| Series: | Folia Medica |
| Subjects: | |
| Online Access: | https://foliamedica.bg/article/64339/download/pdf/ |
| _version_ | 1819107617417461760 |
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| author | Rujuta P. Mistry Chainesh Shah Rakesh Jat |
| author_facet | Rujuta P. Mistry Chainesh Shah Rakesh Jat |
| author_sort | Rujuta P. Mistry |
| collection | DOAJ |
| description | Introduction: Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodipine besylate (AML) is required in this type of patients. Aim: A simple, selective and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in synthetic mixture. Materials and methods: Chromatographic separation was performed on a reversed-phase Luna C18 100Å column (250 mm × 4.6 mm i.d., particle size 5 μ) using an isocratic elution of mobile phase consisting of methanol and acetonitrile (pH 3.5 adjusted by ortho-phosphoric acid) (60:40 v/v) at a flow rate of 1.0 ml/min. Results: Ultraviolet (UV) detection was performed at 242 nm and retention time of telmisartan, rosuvastatin calcium and amlodipine besylate was found to be 2.67, 4.70, and 7.44 min, respectively. The calibration curve was linear (correlation coefficient >0.999) in the selected range of analyte. Conclusions: The method was validated for accuracy, precision, linearity, limit of detection, limit of quantitation and ruggedness. The system suitability parameter, such as theoretical plate, asymmetry, and resolution between standard five replicate were well within the limits.   |
| first_indexed | 2024-12-22T02:56:53Z |
| format | Article |
| id | doaj.art-9babf234608c4b8fb4a31f276900af16 |
| institution | Directory Open Access Journal |
| issn | 1314-2143 |
| language | English |
| last_indexed | 2024-12-22T02:56:53Z |
| publishDate | 2022-02-01 |
| publisher | Pensoft Publishers |
| record_format | Article |
| series | Folia Medica |
| spelling | doaj.art-9babf234608c4b8fb4a31f276900af162022-12-21T18:41:15ZengPensoft PublishersFolia Medica1314-21432022-02-0164110310910.3897/folmed.64.e6433964339RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combinationRujuta P. Mistry0Chainesh Shah1Rakesh Jat2Shri Jagdishprasad Jhabarmal Tibrewala UniversitySigma Institute of PharmacyShree Jagdishprasad Jablamer Tiberwala UniversityIntroduction: Dyslipidemia-hypertension proves to be a major risk factor for cardiovascular diseases. In order to achieve better adherence and cost-effectiveness than free equivalent combination therapies, a fixed-dose combination therapy with telmisartan (TEL), rosuvastatin calcium (ROS) and amlodipine besylate (AML) is required in this type of patients. Aim: A simple, selective and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in synthetic mixture. Materials and methods: Chromatographic separation was performed on a reversed-phase Luna C18 100Å column (250 mm × 4.6 mm i.d., particle size 5 μ) using an isocratic elution of mobile phase consisting of methanol and acetonitrile (pH 3.5 adjusted by ortho-phosphoric acid) (60:40 v/v) at a flow rate of 1.0 ml/min. Results: Ultraviolet (UV) detection was performed at 242 nm and retention time of telmisartan, rosuvastatin calcium and amlodipine besylate was found to be 2.67, 4.70, and 7.44 min, respectively. The calibration curve was linear (correlation coefficient >0.999) in the selected range of analyte. Conclusions: The method was validated for accuracy, precision, linearity, limit of detection, limit of quantitation and ruggedness. The system suitability parameter, such as theoretical plate, asymmetry, and resolution between standard five replicate were well within the limits.  https://foliamedica.bg/article/64339/download/pdf/accuracyICH guidelinemobile phaseprecision |
| spellingShingle | Rujuta P. Mistry Chainesh Shah Rakesh Jat RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination Folia Medica accuracy ICH guideline mobile phase precision |
| title | RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination |
| title_full | RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination |
| title_fullStr | RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination |
| title_full_unstemmed | RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination |
| title_short | RP-HPLC method development and validation for simultaneous estimation of telmisartan, rosuvastatin calcium, and amlodipine besylate in combination |
| title_sort | rp hplc method development and validation for simultaneous estimation of telmisartan rosuvastatin calcium and amlodipine besylate in combination |
| topic | accuracy ICH guideline mobile phase precision |
| url | https://foliamedica.bg/article/64339/download/pdf/ |
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