Sumithra, S (2017) Development of Validated UV Spectroscopic and Chromatographic Methods for the Estimation of Isradipine in Bulk Drug and Butylated Hydroxyanisole in Selected Food Stuffs. Masters thesis, Sri Ramakrishna Institute of Paramedical Sciences, Coimbatore.
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Abstract
INTRODUCTION: Pharmaceutical analysis is a branch of chemistry, which involves the series of process for the identification, determination, quantitation and purification. This is mainly used for the separation of the components from the mixture and for the quantification of the compounds.The modern pharmaceutical analysis entails the following activities like, 1. Analysis of drug substances in bulk drug 2. Degradation and impurity analysis of drug substances 3. Finger print analysis of harmful organic substances in food materials 4. Food and cosmetic analysis 5. Preformulation analysis 6. Analysis of solid dosage forms 7. Analysis of injectable dosage forms 8. Development of new dosage forms 9. Method development 10. Method validation 11. Biological analysis 12. Kinetic studies 13. Food - food interaction and food - drug interaction studies etc. AIM AND OBJECTIVE OF THE WORK:Literature survey reveals that various analytical methods has been developed and validated for the estimation of isradipine using RP-HPLC. Only one method has been reported on UV spectrophotometric method for the determination of isradipine in solid lipid nanoparticles. However, no method has been reported on HPTLC technique for the estimation of isradipine in bulk and its application to degradation studies. Apart from this the presence work aim for the analysis of butylated hydroxyanisole in selected food stuffs. Butylated hydroxyanisole is a phenolic antioxidant which is used to prevent rancidity of fats and oils in food by protecting against oxidation. When the food additives amendment was enacted (1958), BHA were listed as common preservative and considered generally recognized as safe (GRAS). GRAS regulations limit BHA to 0.02% or 200ppm of the fat or oil content of the food products. Based on animal studies, the national toxicology program has concluded that BHA is reasonably anticipated to be a human carcinogen. Hence this project aims at quantifying of BHA present in locally available various food products to check whether the BHA are within the acceptable limit given in FDA using modern analytical techniques like RP-HPLC and RP-HPTLC. Hence the objective of the work, Development of validated UV spectroscopic method and stability indicating HPTLC method for the estimation of isradipine in bulk drug. Development of validated of RP- HPLC and RP- HPTLC method for the estimation of butylated hydroxyanisole in various food products. SUMMARY AND CONCLUSION: An attempt has been made to develop validated UV spectroscopic and stability indicating HPTLC methods for the estimation of isradipine in bulk drug and development of validated RP-HPLC and RP-HPTLC methods for the estimation of butylated hydroxyanisole in selected food stuffs. A simple and sensitive UV spectroscopic method has been developed for the estimation of isradipine in bulk drug. Isradipine exhibited maximum absorbance at 326nm in methanol. Beer’s law was obeyed in the concentration range of 5- 50μg/ml. The % recovery values close to 100% indicated the accuracy of the method developed. More over the data of analysis was supported by RSD values. HPTLC method was developed for isradipine in bulk drug on silica gel 60 F254 TLC plates using mobile phase of toluene: methanol: glacial acetic acid (9:1:0.05% v/v/v) and detection was carried out at 331nm. The Rf value of isradipine was 0.34 (±0.03). The percentage recovery of isradipine was found to be 101.3± 0.35 for 50% and 101.0± 0.36 for 100% with coefficient variation 0.9994. The drug was subjected to acid hydrolysis, alkaline hydrolysis, oxidation, thermal and photolytic degradation. The degradation study indicated isradipine was susceptible to acid hydrolysis and alkaline hydrolysis. The degradation products were well resolved from the pure drug with significant differences in Rf values. The Rf value of isradipine was 0.34± 0.03 and acid degradants were appeared at the Rf value of 0.15 and 0.51. The Rf value of alkaline degradant was 0.20. The comparative study is tabulated in table 32.
| Item Type: | Thesis (Masters) |
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| Additional Information: | REG.No. 261530105 |
| Uncontrolled Keywords: | UV Spectroscopic ; Chromatographic Methods ; Isradipine ; Bulk Drug ; Butylated Hydroxyanisole ; Food Stuffs |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 03 Apr 2018 07:02 |
| Last Modified: | 03 Apr 2018 07:02 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/6821 |
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