DEVELOPMENT AND VALIDATIONOF OF STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ACOTIAMIDE HYROCHLORIDEAbstract
A simple and rapid stability indicating HPLC method for acotiamide hydrochloride was developed and validated. The stationary phase used was thermo gold cyno (250 × 4.6 mm) 5 μ with a mobile phase consisting of mixture of acetonitrile and 10 mM KH2PO4 in water in the ratio of 80:20 v/v at a flow rate of 0.8ml/min. Detection was carried at 284 nm. The retention time observed was 8.1 ± 0.2 min. The column was maintained at ambient temperature and 20 μl of solutions were injected. The eluted compound was detected by using PDA detector. The linear regression analysis data for calibration plot show good relationship with coefficient of regression value, r2=0.99 in the concentration range 10-50 μg/ml. The stress degradation studies were performed as per ICH guidelines. Acotiamide hydrochloride degraded with acid/base hydrolysis, thermal, oxidation and photolytic stress. The method was validated as per ICH Q2A (R1) guideline with respect to linearity, accuracy, precision, specificity and robustness. This method can be used for monitoring the stability of acotiamide hydrochloride.
M. C. Damle * and U. V. Harne
Department of Quality Assurance, All Iindia Shri Shivaji Memorial Society’s College of Pharmacy, Pune, Maharashtra, India.
13 June, 2018
26 July, 2018
03 August, 2018
01 October, 2018