Original Articles: 2014 Vol: 6 Issue: 3
Method development, validation and dissolution studies of ranitidine in its pharmaceutical dosage under different conditions by spectrophotometry
Ranitidine is a common drug used as antacid. In the present study, method (under International Conference of harmonization (ICH) Guidelines) for the validation of Ranitidine in its formulation (Zantac 300mg), was developed spectrophotometrically at max l = 314 nm. The medium of dissolution was water, at 300C and 370C. The concentration of the drug from 1 to 35 ppm was prepared and the regression of the curve was Y = 0.031x -0.014, R2 = 999.The percentage of relative standard deviation (RSD) 75.3, limit of detection (LOD) 0.47, limit of quantization (LOQ) 1.57. Method detection limit (MDL) value 0.47 (t-value 1.56) was determined. The calculated values of Sandells sensitivity and the molar absorptivity were 0.00301384 m g / ml / cm2 and 4.4´106M-1cm-1 respectively. The average recovery of the solution (average of two results of recovery) was made to 99.82%. The label claim was made from the average of two verification test as 100. The solution was stable up to 24 hours, and other analytical parameters were also verified simultaneously.