Gokul, L (2020) Development of Validated Analytical Methods for the Determination of Macitentan from Tablet Dosage Form and its Bioanalytical HPTLC Method in Human Plasma. Masters thesis, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore.
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Abstract
An attempt has been made to develop validated analytical and bioanalytical methods for the determination of pulmonary arterial hypertension drug macitentan from bulk drug and human plasma. The developed methods were validated according to ICH guidelines for analytical procedures and USFDA & EMEA guidelines for bioanalytical procedures. PART 1: ANALYTICAL METHOD DEVELOPMENT For the determination of macitentan in bulk drugs; precise and accurate HPLC and spectroscopic methods were developed. The HPLC method uses a common reversed stationary phase (C18), simple and non-toxic mobile phases producing fast and efficient separation. The method was shown to be sufficiently selective and sensitive to detect the intermediates along with API. The proposed spectroscopic method is rapid, less time consuming and does not require elaborate treatment compared to the chromatographic techniques. ➢ The developed method was found to be simple, sensitive and cost effective. ➢ The developed method could estimate macitentan within a short run time. PART 2: BIO-ANALYTICAL METHOD DEVELOPMENT A sensitive and reliable hptlc method was developed for determination of macitentan in human plasma. Acceptable precision and accuracy were obtained within the calibration range. The proposed methods have advantages like good extraction efficiency and short analysis time. This method could be used by laboratories for their routine analysis of macitentan and for performing bioequivalence and TDM studies of macitentan.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261815101 |
| Uncontrolled Keywords: | Validated Analytical Methods, Determination of Macitentan, Tablet Dosage Form, Bioanalytical HPTLC Method, Human Plasma |
| Subjects: | PHARMACY > Pharmaceutical Chemistry |
| Depositing User: | Ramakrishnan J |
| Date Deposited: | 21 Apr 2022 05:16 |
| Last Modified: | 21 Apr 2022 05:16 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/19352 |
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