Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Manidipine Hydrochloride in Pharmaceutical Dosage Form
PharmaTutor (November- 2014)
ISSN: 2347 - 7881
(Volume 2, Issue 11)
Received On: 23/09/2014; Accepted On: 26/09/2014; Published On: 01/11/2014
AUTHORS: Bhavik S. Patel*, Chetan A. Prajapati
Department of Quality Assurance
Pacific College of Pharmacy, Udaipur, Rajasthan, India
A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for determination of Manidipine HCL. novel stability-indicating RP-HPLC method has been develop and validated for quantitative analysis of Manidipine HCL in in its pharmaceutical dosage forms using Column -Inertsil ODS 3v column (150 mm x 4.6 mm i.d., 5 μm) with Phosphate buffer (pH-2.2) : Acetonitrile (60:40) as isocratic mobile phase at a flow rate of 1.4 ml/min and wavelength of 228 nm. The calibration curves were linear over the concentration ranges of 20-150 μg/ml for Manidipine HCL. The limit of detection (LOD) and limit of quantification (LOQ) for Manidipine HCL were 0.48 and 1.47 μg/ml.Recovery of Manidipine HCL the pharmaceutical dosage form ranged from 99.89-100.71%.
Manidipine HCL was subjected to stress conditions (Hydrolysis (acid, base), oxidation, thermal and photo degradation) and the stressed samples were analysed by use of the method. Degradation was observed in acid, base, and 30% H2O2.
How to cite this article: BS Patel, CA Prajapati; Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Manidipine Hydrochloride in Pharmaceutical Dosage Form; PharmaTutor; 2014; 2(11); 89-101