Argentimetric assay of ranitidine in bulk drug and in dosage forms

Abstract

Two simple, rapid and cost-effective methods based on titrimetric and spectrophotometric techniques are described for the assay of RNH in bulk drug and in dosage forms using silver nitrate, mer- cury(II)thiocyanate and iron(III)nitrate as reagents. In titrimetry, an aqueous solution of RNH is treated with measured excess of silver nitrate in HNO 3 medium, followed by determination of unreacted silver nitrate by Volhard method using iron(III) alum indicator. Spectrophotometric method involve the addi- tion a known excess of mercury(II)thiocyanate and iron(III)nitrate to RNH, followed by the measurement of the absorbance of iron(III)thiocyante complex at 470 nm. Titrimetric method is applicable over 4-30 mg range and the reaction stoichiometry is found to be 1:1 (RNH: AgNO 3 ). In the spectrophotometric method, the absorbance is found to increase linearly with concentration of RNH which is corroborated by the correlation coefficient of 0.9959. The system obey Beer’s law for 5-70 μg mL -1 . The calculated apparent molar absorptivity and sandell sensitivity values are found to be 3.27 × 10 3 L mol -1 cm -1 , 0.107 μg cm -2 respectively. The limits of detection and quantification are also reported for the spectrophoto- metric method. Intra-day and inter-day precision and accuracy of the methods were evaluated as per ICH guidelines. The methods were successfully applied to the assay of RNH in formulations and the results were compared with those of a reference method by applying Student’s t and F-tests. No interference was observed from common pharmaceutical excipients. The accuracy of the methods was further ascertained by performing recovery tests by standard addition method.