Development and Validation of Stability Indicating high performance liquid chromatographic Method for Indapamide Patel Rucha A1,*, Patel Meghna P1, Raj Hasumati1, Shah Nehal2 1Department of Quality Assurance, Shree Dhanvantry Pharmacy College, Kim, Surat, Gujarat, India 2Dharmaj Degree of Pharmacy, Dharmaj, Anand, Gujarat, India *Corresponding Author E-mail: ruchajigar6114@gmail.com
Online published on 29 January, 2016. Abstract An approach of forced degradation study was successfully applied for the development of a stability-indicating high performance liquid chromatographic method for Indapamide in the presence of its degradation products. In the present study a simple, accurate and precise reverse phase liquid chromatographic method has been developed of Olmesartan Indapamide in bulk. Developed Method was achieved on symmetry C18 (150 mm × 4.6 mm, 5 μ) column using a Acetonitrile: 0.02 M Na2HPO4(45:55 v/v) mobile phase and pH 7 adjusted with ortho phosphoric acid. Isocratic elution mode at a flow rate of 1.0 ml/min at Room temperature with a load of 20μl Injection volume. The detection was carried out at 240 nm. The linearity of the proposed method was investigated in the range of 10–50 microg/mL (r2 = 0.998) for Indapamide. The retention time of Indapamide was found to be around 4.79 min and 7.59 min respectively. The drug substances were subjected to stress conditions of acid hydrolysis, base hydrolysis, Oxidative, photolytic and thermal. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, robustness, LOD and LOQ. Top Keywords Indapamide, Hypertension, stability study. Top |