1Department of Pharmaceutical analysis, C.L.Baid Metha College of Pharmacy, Jyothinagar, Thoraipakkam., Chennai-600 097, Tamilnadu. India
2Orchid Chemical and Pharmaceutical Ltd (R&D), Shollinganallur, Chennai, Tamilnadu, India
A simple method for the detection of Benzenesulphonic acid content in Amlodipine Besylate drug substance using ion chromatography with suppressed conductivity detection is presented. A mixture of 1.3 mM Sodium carbonate and 2.0 mM Sodium bicarbonate was used as an eluant. The method showed linear responses over the sample target concentration ranges 35–65μg/ml.The correlation coefficient was found to be 0.9985.The accuracy of the method was determined by preparing the sample concentration in the ranges 70%, 100% and 130% in triplicate and the % recovery was found to be within 98.0 to 102.0.The Method precision and the intermediate precision were demonstrated by the relative standard deviations (R.S.D) of <1% for both the analyst. The Ruggedness was determined by changing the variables such as column, instrument and different analyst on different days. The method was fully validated for the determination of Benzenesulphonic acid in Amlodipine Besylate drug substance.
Benzenesulphonic acid, Ion chromatography, Amlodipine Besylate, conductivity detection
