Devi, M (2017) Analytical Method Development and Validation of Acetylcysteine and Taurine in Tablet Dosage Form by Using RP-HPLC. Masters thesis, Arulmigu Kalasalingam College of Pharmacy, Krishnankoil.
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Abstract
The drug analysis plays an important role in the development of drugs, their manufacture and the therapeutic use. Pharmaceutical industries rely upon quantitative chemical analysis to ensure that the raw materials used and final product obtained meets the required specification. The number of drugs and drug formulations introduced in to the markets has been increased at a disturbing rate. These drugs or formulation may be either in the new entities in the market or partial structure modification of the existing drugs or novels dosage forms or multi component dosage forms. AIM OF WORK: The present work aims at developing newer analytical methods for acetylcysteine and taurine in tablet dosage forms by using RP-HPLC, that are simple, accurate, rapid, precise, sensitive and reliable. PLAN OF WORK To validated a method for analytical quantitation of assay in acetylcysteine and taurine in tablets dosage form. To give a general ICH guidelines for the validation of methods aim for the quantitation of acetylcysteine and taurine in tablets dosage form. Obtaing results with improved accuracy and precision. OBJECTIVE OF WORK: To develop analytical and validation method for the estimation of of acetylcysteine and taurine in tablet dosage form by using RP-HPLC method. CONCLUSION OF ACETYLCYSTEINE: Cosmosil, C18, 250×4.6mm 5μm or equivalent as the stationary phase. Mobile phase is sodium metabisulphite solution adjusts the pH 3 using ortho phosphoric acid and flow rate 1 mL/ mins. Specificity no peak was observed at the retention time of acetylcysteine in the chromatogram of placebo. System precision shows %RSD value obtained was below 1. Retention time of acetylcysteine is 13.01. Correlation of coefficient for acetylcysteine is tailing factor of acetylcysteine is 0.9998. Quantitative estimation of acetylcysteine gives accuracy lies between which 98.89 – 101.46% By using to system to system suitability and analyst to analyst variability all the parameters met the system suitability. Percentage purity of acetylcysteine is 99.67%. CONCLUSION OF TAURINE Cosmosil, C18, 250×4.6mm5μm or equivalent as the stationary phase. Mobile phase is equally mix the Mobile phase A and B. pH 7.2 and flow rate 1 mL/ mins. Specificity no peak was observed at the retention time of taurine in the chromatogram of placebo. System precision shows %RSD value obtained was below 1. Retention time of taurine is 5.41. Correlation of coefficient for taurine is tailing factor of taurine is 1.56. Quantitative estimation of taurine gives accuracy lies between which 99.12 – 101.68 % By using to system to system suitability and analyst to analyst variability all the parameters met the system suitability. Percentage purity of taurine is 99.80%. The results obtained in this study demonstrate that the estimation of taurine in tablet dosage form by RP-HPLC method described is specific, linear, accurate, precise, rugged and robust. The method is suitable for its intended use.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Acetylcysteine ; Taurine ; Tablet Dosage Form ; RP-HPLC |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 21 Dec 2017 07:28 |
| Last Modified: | 21 Dec 2017 07:28 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/4659 |
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