Sunday, August 2, 2009

chromatogram supplied with the reference standard (400 ml of methanol is usually suitable) and (c) a detection wavelength of about 226 nm.Inject

20 pl of solution (3). A strong peak due to 4-hydroxyphenylacetamide and the diol, which are not normally resolved, elutes within 5 minutes of injection and peaks due to the tertiary a mine and 4-(2-hydroxy-3isoprophlaminopropoxy)phenylacetic acid (blacker acid) elute after the principal peak. Adjust the setting of the, amplifier so that the height of the peak due to the tertiary amine is between 30% and 80% of full-scale deflection on the chart paper. Measure the height (a) of the peak due to the tertiary amine and the height chromatogram supplied with the reference standard (400 ml of methanol is usually suitable) and (c) a detection wavelength of about 226 nm.Inject (b) of the lowest part of the curve separating this peak from the principal peak .The test is not valid unless a is greater than 3b. If, in exceptional circumstances, the lertiary amine peak appears as a doublet, reduce the concentration of sodium octyl sulphate in the mobile phase to a point where a single peak is obtained and.if necessary, reduce the polarity of the system to correct for change in retention time of the principal component. Inject separately 20 pl of each of solutions (1) and (2) In the chromatogram obtained with solution (1) the area of any secondary peak with a retention time greater than that of the peak due to 4-hydroxyphenyl-acetamide and the diol is not greater than half the area of the principal peak in the chromatogram obtained with solution (2). Calculate the sum of the areas of these secondary peaks as a percentage with reference to the area of the principal peak in the chromatogram obtained with solution (2), assuming this to be equivalent to 0.5% Ignore any peak the area of which is less than 10% of the area of the principal peak in the chromatogram obtained with solution (2). Sulphated ash. Not more than 0.1%, Appendi* 322 Loss on drying; Not more than 0.5%, determined on 1 g by drying in an oven at 105*. Appendix 8.6. Assay: Weigh accurately about 0.2 g. dissolve in 80 ml of anhydrous glacial acetic acid and carry out Method A for non-aqueous titradon, Appendix 3.45, determining the end-point potentiometrically. Perform a blank determination and make any necessary correction. Each ml of 0.1M perchlonc acid is equivalent to 0.026S3 g of C14H22N2O3-ATENOLOL TABLETS Usual strengths. 50 mg. 100 mg. STANDARDSAtenolol Tablets contain not less than 92.5 per cant and not more than 107.5 per cent of the stated amount of atenolol. C14H22N2O3- Identification: A Heat a quantity of the powdered tablets equivalent to about 0 1 g of Atenolol with 15 ml of methanol to 50°, shake for 5 minutes, filter (Whatman No 42 paper is suitable) and evaporate the filtrate to dryness on a water-bath. Warm the residue with 10 ml of 0.IM hydrochloric acid. shake and filter Add to the filtrate sufficient 1M sodium hydroxide to make it alkaline, extract with 10 ml of chlorofor. dry by shaking

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