Author(s)

Mohammed Nazeerunnisa¹, Lakshmi Garikapati², Syama Sundar Bethanabhatla^1,3*

¹Department of Chemistry, Acharya Nagarjuna University, Guntur, India.
²Centre for Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Hyderabad, India.
³Yogi Vemana University, Kadapa, India.

An isocratic stability-indicating reversed phase high performance liquid chromatographic method (RP-HPLC) was developed for determination of process related impurities and assay of darifenacin hydrobromide (DRF) in bulk drugs. DRF was subjected to various stress conditions such as hydrolysis (acid, base, and neutral), oxidation, photolysis and thermal degradation as per International Conference on Harmonization (ICH Q1A(R2) and Q1B) prescribed conditions to investigate the stability-indicating ability of the method. Significant degradation was observed during acidic hydrolysis and oxidative stress conditions. The chromatographic separation was accomplished on a Prodigy C₈ column (250 × 4.6 mm, 5 μm) with mobile phase consisting of 0.05 M ammonium acetate (pH adjusted to 7.2 by using ammonia solution) and methanol (36% acetonitrile) in 35:65 v/v ratio in an isocratic elution mode at a flow rate of 1.0 mL/min at 25°C. Detection of analytes was carried out using photo diode array detector at a wavelength of 215 nm. The developed LC method was validated with respect to accuracy, linearity, precision, limits of detection and quantitation and robustness as per ICH guidelines.

Darifenacin Hydrobromide, Stability-Indicating, Degradation, Validation, RP-HPLC

Nazeerunnisa, M. , Garikapati, L. and Bethanabhatla, S. (2014) Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Darifenacin Hydrobromide in Bulk Drugs. American Journal of Analytical Chemistry, 5, 1239-1248. doi: 10.4236/ajac.2014.517130.