DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR QUANTIFICATION OF ACETIC ACID CONTENT IN AMLODIPINE BESYLATE
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2019, Vol 11, Issue 4
Abstract
Objective: To develop and validate a simple and accurate cost-effective titrimetric method according to International Conference Harmonization (ICH) guidelines for acetic acid content in Amlodipine Besylate. Methods: The titration based on general acid-base reaction to form water and salt. Sodium hydroxide act as a strong base and titrated against weak acid (acetic acid). Phenolphthalein used as an indicator and colorless to pink is the endpoint. Sodium hydroxide is standardized with primary standard potassium hydrogen phthalate. Results: The method was linear in the range of 0.75 to 30.25 μg/ml with a correlation coefficient 0.9999. Limit of detection (LOD) and limit of quantitation (LOQ) value were found to be 0.61 and 1.85 μg/ml, respectively. The percentage recovery (98.20–99.97%) and percentage relative standard deviation (%RSD) is less than 2% within the acceptable limit of ICH guidelines. The robustness and ruggedness results were excellent. Method is accurate and precise, no interference from excipients. Conclusion: A new analytical titrimetric method was developed and validated as per ICH guidelines for the determination of acetic acid content in amlodipine. This proposed method applied for routine analysis of acetic acid content in bulk and pharmaceutical formulations of amlodipine besylate.
Authors and Affiliations
Sk Manirul Haque, Ayman Ahmad
Keywords
Related Articles
- EP ID EP565390
- DOI 10.22159/ijpps.2019v11i4.31672
- Views 146
- Downloads 0
ANTI-INFECTIVE COATING OF GENTAMICIN SULPHATE ENCAPSULATED PEG/PVA/CHITOSAN FOR PREVENTION OF BIOFILM FORMATION
Objective: The main aim of the current study is to show Anti-infective coating on biomedical implants, one of the novel approaches to control the biofilm formation.Methods: In this study, the coating was employed by the...
PHYTOCHEMICAL STUDY AND THE ANTIPROLIFERATIVE ACTIVITY OF INULA VULGARIS SPECIES GROWN IN LEBANON
Objective: Cancer represents the second leading cause of death after stroke and heart diseases. Plant extracts have long been used in traditional medicine for the prevention and treatment of many illnesses, including som...
Article Has Been Withdraw From Publication
Article Has Been Withdraw From Publication
IDENTIFICATION OF POTENTIAL NOVEL EGFR INHIBITORS USING A COMBINATION OF PHARMACOPHORE AND DOCKING METHODS
Objective: Identifying new inhibitors of Epidermal Growth Factor Receptor (EGFR) by virtual screening using a pharmacophore model followed by docking. Methods: A pharmacophore model was developed using a dataset of 77 ch...
FORMULATION AND OPTIMIZATION OF SOLID SELF-NANOEMULSIFYING SYSTEM USING POROUS CARRIERS FOR ORAL DELIVERY OF CINNARIZINE
Objective: The present study aims to utilize the nanotechnology technique to formulate the Cinnarizine (CNZ) in the form of solid self-nano emulsifying system to enhance the dissolution and hence the bioavailability.Meth...