METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF NAPROXEN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC
B. Naveen Kumar, Dr. Srikanth Lingala* and A. Venkatesham
ABSTRACT
While developing the HPLC method, basic chromatographic conditions such as the column, solvents and UV detection employed in this method were taken into account. In selecting the UPLC column, its efficiency and resolution was taken into consideration. Most commercial C18 columns are not stable at high pH on the longer run, thus shortening their life span. Waters Acquity HSS T-3 C18 column (100 × 2.1 mm, 1.8?m) column was found to be more suitable and stable at this pH. The peak was sharp and distinct. Developing a UPLC method was to reduce the run time of the method and solvent consumption for routine analysis such as assay, dissolution and content uniformity during quality assurance. Detection of Naproxen must adequate at 287 nm. The initial trial was conducted using HPLC and chromatographic separation obtained on a Waters HSS C18 column (100 x 2.1mm, particle size 5?m). The developed method must be validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The method was linear for Naproxen from 20 - 60?g/ml and the linear regression obtained Precision, evaluated by intra- and inter-day assays had relative standard deviation (R.S.D) values within 1.5 %. Recovery data were in the range 99.3-103.2% with R.S.D. values < 1.5 %.
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