Ragavendran, C (2015) Method Development and Validation of Antiretroviral Drugs in Bulk and Pharmaceutical Dosage Forms. Masters thesis, Edayathangudy.G.S Pillay College of Pharmacy, Nagapattinam.
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Abstract
INTRODUCTION: ANALYTICAL CHEMISTRY: Analytical chemistry1 is the branch of chemistry involved in separating, identifying and determining the relative amounts of the components making up a sample of matter. It is mainly involved in the qualitative identification or detection of compounds and the quantitative measurement of the substances present in bulk and pharmaceutical preparation. The newer methods for separating and determining chemical species are known collectively as instrumental methods of analysis. Most of the instrumental methods fit into one of the three following categories viz., spectroscopy, electrochemistry and chromatography. CHROMOGENIC REAGENTS USED IN THE PRESENT INVESTIGATION: Functional groups present in organic drugs determine the way of analyzing them because they are responsible for the properties of substances and determine the identification reaction and the methods of quantitative determination of drugs. Knowing the reactions for detecting functional groups, one can easily analyze any organic drug with a complicated structure. In the present investigation, few visible spectrophotometric methods have been developed for LMV and STV by developing colour in each case with, appropriate reagent. The analytically useful functional groups in the drug have not been exploited completely in developing the new visible spectrophotometric method and so, the drugs have been selected in the present investigation. Different type of reagents like Gibbs reagent, MBTH reagent and BPB reagent were used in the present investigation for developing visible spectrophotometric methods. SUMMARY: Several drugs are available in the form of pharmaceutical formulations to control diseases. Methods of assay for controlling the concentration of these chemicals in the medicine and in the living body are necessary. Pharmaceutical analysis occupies a pivotal role in statutory certification of drugs and their formulations either by the industry or by the regulatory authorities. The complexity of the problem encountered in pharmaceutical analysis coupled with importance of achieving the selectivity, speed, cost, simplicity, precision and accuracy results in new methods of analysis being quickly adopted by pharmaceutical industry. Formulations containing combinations of drugs for potentiating or complementing another in therapy are on the increase. In some cases, no precise analytical methods are reported and quite often the reported procedures need improvements or changes keeping in the view of the advances. Among several instrumental techniques (HPLC, GC, Fluorimetry, NMR, mass spectroscopy covering IR, UV and visible regions) available for assay of drugs, visible spectrophotometric methods depend only on the nature of chemical reaction utilized for colour development and not on sophistication of the equipment. GC method is highly selective and sensitive compared to spectroscopic or other chromatographic methods. GC method is also cost effective as expensive solvents are not required and it is a versatile tool for qualitative and quantitative analysis of drugs and pharmaceuticals. Due to the importance of analysis, present analytical method has been developed for some of the widely used antiretroviral drugs such as lamivudine, zidovudine, stavudine, nevirapine and efavirenz. Hence we planned o develop HPLC, GC and spectrophotometric methods. CONCLUSION: Antiretroviral drugs are medications for the treatment of infection by retroviruses, primarily HIV. When several such drugs, typically three or four, are taken in combination, the approach is known as highly active antiretroviral therapy, or HAART. The American National Institutes of Health and other organizations recommend offering antiretroviral treatment to all patients with AIDS. Although various UV-visible methods have been reported for the estimation of LMV, ZDV and STV it was found that the reagents used in the present study were not used and the methods developed are much sensitive and less time consuming compared to the methods previously develop. The simultaneous estimation of LMV, ZDV and EFZ with UV spectrophotometer using triple point method was not investigated. The work deals with four UV-Visible spectrophotometric methods i.e. oxidation reaction with Cerium (IV) ammonium sulphate, visible spectrophotometric method with BPB, GIBBS reagent and coupling reaction with MBTH reagent. The methods are validated in terms of sensitivity, accuracy and precision. A. Comparative Sensitivity 1> 2 > 3 > 4 B. Comparative accuracy: 3> 4 >2 > 1 C. Comparative precision: 3 > 4 > 1 > 2 Simultaneous estimation of LMV, ZVD and NVP by RP-HPLC was also developed. The retention times of the drugs were less when compared to other methods developed. In terms of sensitivity, accuracy and precision the present developed method has shown good results when compared to the existing method. Lamivudine was quantified by Gas Chromatographic method using Ethyl Chloroformate as a Derivatizing reagent. There were no GC methods reported for lamivudine. LMV analysis was performed after derivatization and the internal standard technique was used for computation. The method development for the assay of LMV was based on its chemical properties. The method developed is very sensitive as the limit of detection is very less. Results of analysis of the pharmaceutical formulations revealed that the proposed methods are suitable for their analysis with no interference from the usual additives. All the methods were found to be linear, precise, accurate, specific and all proved to be sensitive, convenient and effective for the determination of LMV, ZVD, STV, NVP and EFZ in bulk and pharmaceutical dosage forms.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg No.261330958 |
| Uncontrolled Keywords: | Antiretroviral Drugs ; Pharmaceutical Dosage Forms |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 03 Apr 2018 10:03 |
| Last Modified: | 03 Apr 2018 10:03 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/6832 |
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