Development and validation of HPLC analytical method for Nepafenac in ophthalmic dosage form (suspension)
Journal Title: Pakistan Journal of Pharmaceutical Sciences - Year 2014, Vol 27, Issue 5
Abstract
The aim of the present study was to develop and validate an analytical method for the estimation of nepafenac as a raw material as well as in dosage form (suspension) by using reverse phase high performance liquid chromatographic (RP-HPLC). The target was to obtain an easy, rapid, reproducible as well as a rugged method. The HPLC system that was used in the proposed study was LC-20AD liquid chromatograph equipped with SPD-20A UV-VIS detector. The separation was performed on C18 column which was attached with loop 20µl. Elution was done at ambient temperature with a mobile phase consisting of acetonitrile: Water (40: 60v/v) at a flow rate of 1ml/min and at a wavelength of 254 nm. The proposed method was validated as per the ICH guidelines. The retention time for nepafenac was 7.49 minutes (% CV=0.0076). The percentage coefficient variation (CV) of six consecutive peak areas of injections was 0.34% with tailing factor 1.76. The peak area responses were linear within the concentration range of 0.078-20.0μg/ml (R2=0.9993). The sensitivity of the method could be evaluated by limits of detection (LOD) (0.0195μg/ml) and limits of quantitation (LOQ) (0.039μg/ml). Nepafenac drug is s in its diluent that could see by intra-day (% CV =0.45-1.96) and inter-day variation (%CV=0.173-1.898%). The accuracy and recovery results of 80%, 100% and 120% were 97.40% to 102.10% with % CV of 0.3201% to 1.3496%. The robustness and ruggedness of the method are significantly broader and is reproducible. It could be used as a more convenient, efficient, easy and time saving method for the analysis of drug in raw material as well as in dosage form (ophthalmic suspension).
Authors and Affiliations
Shahnaz Usman , Muhammad Akram , Asif Aziz , Venkat Ramesh , Omar Abdulraheem Sarheed
Keywords
Related Articles
- EP ID EP147646
- DOI -
- Views 110
- Downloads 0
Antibacterial, antioxidant, anti-cholinesterase potential and flavonol glycosides of Biscutella raphanifolia (Brassicaceae)
Different extracts of the aerial parts of Biscutella raphanifolia (Brassicaceae), which has not been the subject of any study, were screened for the phytochemical content, anti-microbial, antioxidant and anti-choli...
Pitavastatin is a potent anti-inflammatory agent in the rat paw model of acute inflammation
Statins are used extensively as anti-hyperlipidemic agents. In addition to curtailing cholesterol synthesis they have been found to have multiple actions unrelated to cholesterol lowering“ the pleiotropic effects,”...
Influences of Bushen Xingnao Decoction on expression of vascular endothelial growth factor, IL-1β and tumor necrosis factor-α in vascular dementia rats
To observe influences of Bushen Xingnao Decoction (BSXND) on expression of vascular endothelial growth factor (VEGF), IL-1β and tumor necrosis factor-α (TNF-α) in brain tissues and serum level of vascular dementia...
Synthesis of 2-{(5-phenyl-1,3,4-Oxadiazol-2-yl)sulfanyl}-N-substituted acetamides as potential antimicrobial and hemolytic agents
A new series of N-substituted derivatives of 2-{(5-phenyl-1,3,4-Oxadiazol-2-yl)sulfanyl}acetamides was synthesized. The synthesis was carried out by converting benzoic acid (1) into ethyl benzoate (2), benzohydrazi...
Formulation and in vivo evaluation of diclofenac sodium sustained release matrix tablet: Effect of compression force
In the present study, Diclofenac Sodium (DS) matrix tablets were prepared by direct compression method under different compression forces (5, 10, 15 and 20 KN), using ethylcellulose as matrix forming materi...