Abstract: A new simple, accurate, precise, sensitive and selective reverse phase high performance liquid chromatographic (HPLC) method has been developed and validated for the determination of Ivabradine HCl in bulk and tablet formulation. Chromatographic separation was performed on C18 (250 x 4.6 mm id, 5 µm) column using, ammonium acetate buffer pH (6.2) : Methanol (40:60 v/v) as mobile phase with flow rate 1ml/min at 281 nm with injection volume 10µl/ml. Retention time of Ivabradine HCl was found to be 6.9 min. The calibration curve was found to be linear between 40 to 80 µg/ml with regression coefficient 0.9974. The method is validated for specificity, linearity, accuracy, precision and robustness, found to be within the specified limit. The IV undergoes degradation under acidic, basic, oxidative, thermal and photolytic conditions. The LOD and LOQ for IH were 1.3µg/ml and 3.95µg/ml, respectively. The method was found to be robust with better accuracy and precision having % RSD value less than 2. The proposed method can be applicable for the estimation of Ivabradine HCL during routine analysis and stability studies.
Keywords: Ivabradine HCl, RP-High Performance Liquid Chromatography (HPLC), Validation, Forced degradation, ICH.
Title: ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF IVABRADINE HCL IN BULK AND FORMULATION
Author: Gauri Korgaonkar, Vaishali B. Jadhav, Ashish Jain
International Journal of Thesis Projects and Dissertations (IJTPD)
Research Publish Journals
