Mallikharjuna Rao, P (2012) Development and Validation of RP-HPLC Method for Quantitative Analysis of Naratriptan Hydrochloride Tablet. Masters thesis, K M College of Pharmacy, Madurai.
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Abstract
The present studies is to develop simple and validated RP-HPLC method by isocratic mode for the quantification of naratriptan Hcl in tablet formulation. The plan of present work is as follows: Method Development, Selection of wavelength, Selection of initial separation conditions, Selection of mobile phase (pH, peak modifier, solvent strength and flow rate), Nature of the stationary phase, Selection of separation method, Validation of the developed method, The developed method was validated by using the various validation parameters such as, Accuracy, Precision, Linearity, limit of detection (LOD) and limit of quantitation (LOQ), Selectivity / Specificity, Robustness / ruggedness. As the literature survey reveals that there are very few method have been reported for the determination of the naratriptan Hcl and so a modified RP-HPLC method was developed for the estimation of drug in tablet dosage form and validated. HPLC waters ALLIANCE 2695 with column spursil C18, 250 X 4.6 mm, 5 μ AGILENT was used. A volume of 10 μl of drug solution was injected and eluted with the mobile phase of potassium di hydrogen phosphate buffer pH 7.2: acetonitrile in the ratio of 7:3 v/v, which was pumped at the flow rate of 1.0 ml and detected by UV detector at 224 nm. The peak of naratriptan was found well separated at 3.285 min. The developed method is economical, easy and it gives sharp peak with high resolution. The developed method is applied for the determination of naratriptan Hcl. The assay results comply to the label claim of the formulation. The developed method was validated as per ICH guidelines using parameters like Accuracy, Precision Linearity and Range, Specificity, Ruggedness, LOD, LOQ and Robustness. Hence the developed method is found to be satisfactory and it complies with all validation parameters. So this developed method can be used for the routine analysis of naratriptan Hcl in tablet dosage form.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | RP-HPLC Method; Naratriptan; Hydrochloride Tablet; Isocratic |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 10 Aug 2017 06:03 |
| Last Modified: | 10 Aug 2017 06:03 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/2619 |
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