1Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, A.P, India
2Department of Chemical Engineering, JNTU College of Engineering, Anantapur, A.P, India
3Dept. of Pharmaceutical Analysis, K.V.S.R Siddhartha College of Pharmaceutical sciences, Vijayawada, A.P.
The development and validation of an analytical ultraviolet (UV) spectroscopic method to quantify Darifenacin hydrobromide as a single active moiety in tablet was undertaken. The study was carried out as per USP and ICH guidelines. The proposed method was more sensitive in terms of per cent relative standard deviation (RSD), limit of detection (LOD), limit of quantification (LOQ), linearity and accuracy. Darifenacin Hydrobromide was estimated at 286.6 nm in 10%V/V 3N NaOH solution in methanol with linearity range of 10–100μg/mL, Detection limit 3.723 μg/mL, Quantification limit 11.28 μg/mL, molar absorptivity 4.116 X 103 L/mol/cm and correlation coefficient 0.9988. The recovery studies confirmed the accuracy of the method.
Darifenacin hydrobromide, ICH guidelines, validation
