Method Development and Validation of Taurine and Acetyl Cysteine by Using RP-HPLC Method

An accurate, precise and sensitive HPLC method was developed and validated for the simultaneous estimation of Acetyl Cysteine and Taurine in tablet dosage form. An isocratic separation was carried out using Inertsil (250×4.6mm, 5μ) ODS C-18 RP-column and Phosphate Buffer: Methanol pH 2.5 (25: 75 v/v) mobile phase carried out at a wavelength of 254nm. The Retention time of Taurine and Acetyl cysteine were found to 2.589 ± 0.004 min and 3.711 ± 0.005 min, respectively with theoretical plate count and asymmetry as per the ICH limits. The % assay of Acetyl cysteine and Taurine were 99.3% for both the drugs. The flow rate was found to be 1ml/min. The linear regression analysis data for the calibration plots showed better linear relationship for Taurine and Acetyl cysteine over a concentration range of 20 to 60 μg/ml and 10 to 30 μg/ml, with regression values of 0.9979 and 0.9999, respectively. The limit of detection and Quantitation of Taurine was found to be 0.001μg/ml and 0.004μg/ml and Acetyl cysteine was found to be 0.005 μg/ml and 0.015μg/ml respectively.