METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF NEBIVOLOL HYDROCHLORIDE AND AMLODIPINE BESYLATE IN TABLET DOSAGE FORMS BY RP-HPLC
Journal Title: International Journal of Pharmaceutical Sciences and Drug Research - Year 2015, Vol 7, Issue 1
Abstract
A simple, specific and precise high performance liquid chromatographic method was developed and validated for Nebivolol HCl and Amlodipine besylate in a combined tablet dosage form. Nebivolol hydrochloride, a long acting, cardioselective β-blocker and Amlodipine besylate, a calcium channel blocker are considered in combination for the treatment of hypertension. The chromatographic separation was performed using Eclipse XDB plus C18 Column (4.6 × 150 mm, 5μm particle size). The mobile phase consisted of combination of 0.01 M Ammonium acetate buffer (pH 4.5) and Acetonitrile in the ratio of 50:50 v/v at a flow rate of 0.8 ml/min with the detection wavelength at 265 nm. Both the drugs showed good linearity in the concentration range of 10-50μg/ml and 5-25μg/ml respectively with a correlation coefficient of 0.999 for both drugs. The retention time for Nebivolol HCl and Amlodipine besylate were found to be 3.553 and 2.970 min respectively. The developed analytical method was validated for linearity, precision, accuracy, ruggedness, robustness, specificity and system suitability, which were within the acceptance limits according to ICH guidelines. The developed method can successfully be employed for routine quality control of Nebivolol HCl and Amlodipine besylate in combined tablet dosage forms.
Authors and Affiliations
Usha Rani N, Satya Priya B, Nagoor Ankani
Keywords
Related Articles
- EP ID EP625051
- DOI -
- Views 57
- Downloads 0
SAFETY, TOLERABILITY AND BIOEQUIVALENCE ASSESSMENT OF A DISPERSIBLE TABLET FORMULATION OF PYRAZINAMIDE
Pyrazinamide is a widely used drug for the treatment of tuberculosis. A 150 mg Dispersible Tablet (DT) formulation of the drug was prepared by Micro Labs, a generic drug company. The formulation was developed for easy ad...
DESIGN AND EVALUATION OF COLON TARGETED DOSAGE FORM CONTAINING MESALAZINE USING PH DEPENDENT POLYMERS
Colonic drug delivery has gained importance not just for the delivery of the drugs for the treatment of local diseases associated with the colon like Crohn’s disease, ulcerative colitis and irritable bowel syndrome but a...
EVALUATION OF IN-VIVO ANTITUMOR ACTIVITY OF ANNONA CRASSIFLORA WOOD EXTRACT
Annona crassiflora is a native tree from Brazilian savanna area of the state of Minas Gerais. The ethanolic extract of A. crassiflora wood was obtained and purified, and an annonaceous acetogenins-rich fraction was obtai...
DEVELOPMENT AND VALIDATION OF SIMPLE UV-SPECTROPHOTOMETRIC METHOD OF QUANTIZATION OF ONDANSETRON HYDROCHLORIDE IN SOLID DOSAGE FORMULATIONS USING HYDROTROPIC SOLUBILIZATION TECHNIQUE
Commonly used organic solvents for spectrophotometric analysis of water insoluble drugs are methanol, ethanol, chloroform, benzene, toluene etc. The main drawbacks of organic solvents include high cost, toxicity, and pol...
EVALUATION OF CLINICAL EFFICACY AND TOLERANCE OF KHASCEEZE –SF COUGH SYRUP
Fifty patients of either sex aged 15 - 65 years entered the study to test the efficacy and tolerability of a herbal preparation known as Khasceeze-SF Cough Syrup. They were studied for cough and related symptoms such as...