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 103
- Downloads 0
Combined use of borneol or menthol with labrasol promotes penetration of baicalin through rabbit cornea in vitro
The permeability of most drugs through the eyes is very limited, so finding safe and effective penetration enhancers is of high importance in current ophthalmology research. In this paper, we use a new approach tha...
In vitro/in vivo effect of Citrus limon (L. Burm. f.) juice on blood parameters, coagulation and anticoagulation factors in rabbits
The genus Citrus of the family Rutaceae includes many species e.g. Citrus indica, Citrus aurantifolia and Citrus limon, among which Citrus limon L. Burm. f. has been reported to have highest antimicrobial activity....
Molecular bonding characteristics of Self-plasticized bamboo composites
Bamboo biomass fibers were gradually separated, prepared, and then self-plasticized for immune composites. The molecular bonding characteristics of the self-plasticized bamboo composites were investigated by Fourie...
Diverse pharmacological properties of Cinnamomum cassia: A review
Cinnamomum cassia is widely utilized as a spice in different cookeries worldwide, especially in Asian cuisines. This herb is also being used in different forms of traditional medicine (Unani, Ayurvedic, Japanese an...
An old dietary regimen as a new lifestyle change for Gastro esophageal reflux disease: A pilot studyAn old dietary regimen as a new lifestyle change for Gastro esophageal reflux disease: A pilot study
Treatment of gastro esophageal reflux disease (GERD) is becoming a challenge for medical profession. Proton pump inhibitors (PPIs) are commonly recommended but many disadvantages of these drugs are being reported,...