Nidhin, George (2019) Analytical Method Development and Validation of Lumefantrine by RP-HPLC. Masters thesis, J.K.K. Nattraja College of Pharmacy, Kumarapalayam.
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Abstract
is considered accurate if the average recovery is not less than 98% and not more than 102%. Precision parameter RSD of six replicate injections should be NMT 2%. The linearity range of Lumefantrine was found to be 100-500 μg/ml in HPLC. Linear regression was not more than 0.999.the values of %RSD was <2 Robustness of assay method is demonstrated by changing the flow rate for 1.4ml/min and 1.8ml/min instead of 1.6ml/min by injecting the 6 replicate injections of standard in 1.4ml/min and 1.8ml/min flow rate and found that system suitability parameters are passed. By changing the column temperature for 30 �c and 40 �c instead of 35 �c by injecting the 6 replicate injections of standard in 30 �c and 40 �c temperature and found that system suitability parameters are passed Ruggedness parameter RSD for the assay values of 6 sample preparations of same batch should not be more than2.0%. The LOD are calculated from the calibration curve by using the formulas LOD = 3 x SD/ bWhere, SD- the estimate is the standard deviation of the peak area of the drugs. b -is slope of the corresponding calibration curvepassed.The LOQ are calculated from the calibration curve by using the formulas LOQ = 10 x SD/ where,limits. These results shows the method is accurate, precise, sensitive, economic & rugged. The HPLC method is more rapid. The proposed method is successfully applied to the bulk dosage form. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261730208 |
| Uncontrolled Keywords: | Analytical Method, Development, and Validation, Lumefantrine, RP-HPLC. |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Thavamani K |
| Date Deposited: | 23 Mar 2022 07:59 |
| Last Modified: | 23 Mar 2022 07:59 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/19086 |
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