Satheshkumar, S (2017) Development of Validated UV Spectroscopic, HPTLC and RP-HPLC Methods for the Simultaneous Estimation of Ledipasvir and Sofosbuvir in Pure and Fixed Dose Combination. Masters thesis, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore.
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Abstract
INTRODUCTION: Pharmaceutical analysis may be defined as the application of analytical procedures used to determine the purity, safety and quality of drugs and chemicals. Most manufacturing industries rely upon both qualitative and quantitative chemical analysis to ensure that the raw materials used meet certain specifications, and also to check the quality of the final product. The examination of raw materials is carried out to ensure that there are no unusual substances present which might be deleterious to the manufacturing process or appear as a harmful impurity in the final product. The final manufactured product is subjected to quality control to ensure that its essential components are present within a pre-determined range of composition, whilst impurities do not exceed certain specified limits. Reasons for developing newer analytical methods for drugs: 1. Marketed drug may not be official in pharmacopoeias. 2. Literature search may not contain complete analytical procedure for such drugs. 3. No proper method may be available for drug in the form of formulation due to interference caused by pharmaceutical excipients. 4. Procedures for the estimation of drug in biological fluids may not be available. 5. Analytical techniques may not be available for the drugs in combination with other drugs. 6. Expenses may be more for reagents and solvents used in existing procedures. 7. There may be difficulties in extraction and separation process and these may not be sensitive and time consuming. AIM AND OBJECTIVE: Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver. During the initial infection people often have no symptoms. Occasionally a fever, dark urine, abdominal pain and yellow tinged skin occurs. The virus persists in the liver 75%- 85%. There is no vaccine currently against hepatitis C (however research in this area is ongoing). Antiviral medicines such as ledipasvir and sofosbuvir (cimivir-L tablet) can cure more than 95% of persons with hepatitis C, which is lifesaving drug. An estimated 143 million people (2%) worldwide are infected with hepatitis C as of 2015. It occurs most commonly in Africa and central and East Asia. Each year 3,99,000 people died for hepatitis C. Literature survey revealed that no Spectrophotometric and HPTLC methods for the simultaneous estimation of Ledipasvir and Sofosbuvir. This combination tablet approved by FDA (10, Oct, 2014) which is a lifesaving drug. Which is not official in any of the pharmacopoeias and hence requires much more investigation. Hence an attempt has been made to develop new, simple and economic and validated methods for the determination of Ledipasvir and Sofosbuvir in bulk and formulation Hence, the objectives of the present work is to develop a validated 1. UV-spectroscopic methods for the simultaneous estimation of ledipasvir and sofosbuvir in bulk and formulation. 2. HPTLC method for the simultaneous determination of ledipasvir and sofosbuvir in bulk and formulation. 3. RP-HPLC method for the simultaneous determination of ledipasvir and sofosbuvir in bulk and formulation. SUMMARY AND CONCLUSION: Each year 3,99,000 people were died for hepatitis C. Ledipasvir and Sofosbuvir are the two anti-viral lifesaving drugs commonly used in combination for treating hepatitis C. The present study deals with development and validation of a two simple, economical UV Spectroscopic methods, and two sensitive, reliable stability indicating HPTLC and HPLC methods for simultaneous estimation of Ledipasvir and Sofosbuvir in pure and fixed dose combination. The UV Spectroscopic methods involved by solving (i)simultaneous equation (ii)second order derivative methods. The two selected wavelengths were 333 nm (
| Item Type: | Thesis (Masters) |
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| Additional Information: | REG.No. 261530104 |
| Uncontrolled Keywords: | Validated UV Spectroscopic ; HPTLC ; RP-HPLC Methods ; Simultaneous ; Ledipasvir ; Sofosbuvir ; Dose Combination |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 03 Apr 2018 06:54 |
| Last Modified: | 03 Apr 2018 06:54 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/6820 |
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