Abstract
A method for determination of the starting materials, [7-hydroxy-1, 3, 6-naphthalenesulfonic acid (TS), G-salt (GS), R-salt (RS), Schaeffer's salt (SS) and naphthionic acid (NA)] and subsidiary colors, [ponceau 6R (P6R), amaranth (R-2) and fast red E (FRE)] in new coccine (R-102) was developed by use of HPLC. The following conditions were used for analysis: column, L-column ODS (4.6mm i. d.×250mm); eluent, gradient elution system of 0.02M ammonium acetate and acetonitrile (hold at 0.02M ammonium acetate for 5min, then 0-30% acetonitrile in 45min); detection for TS, GS, RS, SS and NA at 238nm and subsidiary colors at 510nm.Recoveries of each impurity from R-102 averaged 99.1-103.5%. Ten samples of commercial R-102 were analyzed by the present HPLC method and the impurites were as follows: TS, 0.005-0.044%; GS, 0.044-0.284%; NA, 0.013-0.196%; RS, N. D.; SS, N. D.; P6R, 0.008-0.169%; R-2, N. D. -0.279%; FRE, 0.007-0.100%. The detection limit was 0.001% for each impurity.
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