validation.

ABSTRACTThe main objective of this study was to develop and validate an UV-spectrophotometric method for the estimation of sparfloxacin in 0.1 N HCl (gastric simulatory media) as per ICH guidelines. The ?max for sparfloxacin in 0.1 N HCl was found to be 296 nm. The drug follows linearity in-between the concentration range of 2-12?g/ml with a correlation coefficient value of 0.999. The proposed method was applied onto the bulk and marketed pharmaceutical formulation (tablets) so as to find out contents of drug. Estimated drug was found to be in-between 98.43 to 101.57 % in marketed tablets, a good agreement with the claimed level. The accuracy of the method was verified by recovery experiment performed at three different levels- 75%, 100%, and 125%. The % recovery was found to be in the range of 97.31-101.45%. The accuracy and reproducibility of the method was indicated by low values of % RSD. The precision of the method was studied through intraday and Interday variations and repeatability. The % RSD value< 2 confirmed the precision of developed method. Ruggedness of the proposed method was studied with the help of two analysts. The proposed method was found to be a rapid yet successful tool for routine analysis of sparfloxacin in the bulk and in the pharmaceutical dosage forms. Keywords: Fluorquinolone; sparfloxacin, Quantitative determination, UV, validation.

This paper describes the common analytical method suitable for the estimation of selected triptans (Naratriptan, Sumatriptan succinate, Zolmitriptan) by reversed phase high performance liquid chromatography (RP-HPLC). Chromatographic separations were conducted on Phenomenex Luna, C18 250 X 4.6 mm, 5 microns column at room temperature using 6.8 pH phosphate buffer: acetonitrile (60: 40) as a mobile phase at a flow rate of 1.0ml min-1, while UV detection was performed at 225nm. The retention time was found to be 3.130, 3.153, 2.143min respectively for the selected triptans. The method was found to be linear in the range of 2-10µg ml-1 for all the drugs. The proposed method is having good sensitivity due to low LOD and LOQ values. Analytical recovery was >99.3%. The method was validated statistically and applied for the quantitative analysis of triptans in bulk and formulations.