ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ACETYLCYSTEINE AND TAURINEIN TABLET DOSAGE FORM BY USING RP-HPLC

Simple, accurate, rapid and precise reverse phase high performance liquid chromatographic method has been developed and validated for the determination of acetylcysteine and taurine in tablet dosage. The chromatographic separation was done on Isocratic elution using cosmosilC18, 250 x 4.6 mm, 5µm or equivalent. Flow rate is 1mL/min. Maintain the column temperature of acetylcysteine is 30oC and taurine is 40oC. Detection was carry out at acetylcysteine is 214nm and taurine is 338nm. Good linear relationship was produce acetylcysteine and taurine is 0.9998 and 0.9991. Linearity range is 0.2500mg/mL to 0.7500mg/mL solution stability acetylcysteine and taurine is 24hrs and 12hrs. The method development and validation of acetylcysteine and taurine in according to ICH guidelines. Key words: Acetylcysteine, RP-HPLC, Taurine, Validation