Ricardo, V (2019) Development and Validation of New Analytical Methods for the Estimation of Rufinamide in Bulk and Pharmaceutical Dosage Form. Masters thesis, Jaya College of Paramedical Sciences, Thiruninravur, Chennai.
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Abstract
In the present work, an attempt was made to provide a newer, simple, accurate and low cost spectrophotometric methods and one HPLC method for the effective quantitative determination of Rufinamide as an active pharmaceutical ingredient as well as in pharmaceutical preparations without the interferences of other constituent in the formulations. For routine analytical purposes it is always of interest to establish methods capable of analyzing a large number of samples in a short time period with good accuracy and precision. Spectrophotometric technique, derivative method were applied without using any prior chemical pretreatment in the presence of the strongly overlapping spectra can generate large amounts of data within a short period of analysis. Pharmaceutical analysis occupies a pivotal role in statutory certification of drugs and their formulations either by the industry or by the regulatory authorities. There is a wide scope for the development of new analytical methods for the assay of the above drug. Among several instrumental techniques (HPLC, GLC, Fluorimetry, IR, UV, Visble, NMR, and Mass spectrometry) available for the assay of drugs. HPLC technique has been regarded as the best among various instrumental ones in spite of its sensitivity and maintenance problems. UV Spectrophotometry and RP-HPLC techniques have been used as tools in the present work. The above tools have been used for the development of new analytical methods for the assay of Rufinamide. The contents of the thesis have been divided into nine chapters. Chapter 1 begins with the introduction giving a brief account of pharmaceutical analysis, analytical method development, UV-Spectrophotometry, Zero order Spectrophotometric method, AUC method, High Performance Liquid Chromatography, and analytical method validation. It also includes drug profile of Rufinamide with physicochemical characteristics and specifications for the drug. Chapter 2 explains the objectives of present investigations adopted for selected drug. Chapter 3 surfaces review of literature that gives important details collected from previously published analytical methods for Rufinamide. Chapter 4 presents methodology which is divided into two parts, Part A and Part B. In Part A, elaborated methodologies for the proposed two different UV-Spectrophotometric methods are included while in Part B, detailed methodologies for a RP-HPLC method is included. Chapter 5 consists of results which are divided into two parts, Part A and Part B. In Part A, the results obtained in Zero order and AUC UV-Spectrophotometric methods for determination of Rufinamide are given in their respective tables. In Part B results obtained from RP-HPLC method for estimation of Rufinamide are illustrated in their respective tables. Chapter 6 consists of discussion which discusses about the developed UV spectrophotometric methods and RP-HPLC method. Chapter 7 explains the conclusion in two parts, Part A and Part B respectively. Part A includes the proposed UV spectrophotometric methods for the quantitative estimation of Rufinamide. Part B contains proposed RP-HPLC method for the quantitative estimation of Rufinamide. These methods are validated in terms of sensitivity, accuracy and precision and can be used for the routine determination of Rufinamide in bulk drug and pharmaceutical formulations. Chapter 8 contains the summary. Chapter 9 contains the bibliography.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261731106 |
| Uncontrolled Keywords: | New Analytical Methods, Rufinamide, Pharmaceutical Dosage Form |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ramakrishnan J |
| Date Deposited: | 28 Apr 2022 11:21 |
| Last Modified: | 28 Apr 2022 11:21 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/19536 |
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