ANALYTICAL METHOD DEVELOPMENT & VALIDATION OF ETRAVIRINE IN ITS BULK DOSAGE FORM BY USING RP-HPLC METHOD AS PER ICH GUIDELINES
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2015, Vol 8, Issue 2
Abstract
 Objective: An accurate, precise, rapid and economical reverse phase high performance liquid chromatography (HPLC) method has been developedand validated for the estimation of etravirine in pharmaceutical dosage forms, using an ultraviolet detector.Method: Elution was carried out using a mobile phase consisting of HPLC grade acetonitrile and flow rate was set on 1 ml/minute at 271 nm wavelength. The retention time for etravirine was found to be 1.80 minutes.Result: The method was found to be linear in the range of 10-60 μg/ml. In the linearity study, regression equation and correlation coefficient werefound to be y=16.95x+17.148 and 0.999, respectively. This method was rugged and robust in different testing criteria, limit of detection and limitof quantification was found to be 0.514 μg/ml and 1.713 μg/ml respectively. Accuracy study was carried out in three different concentration leveli.e. 50, 100, 150% and % recovery of the method was found to be 98.6%, 99.08%, 99.17% respectively in three different levels and mean recoverywas 98.95% and hence method was accurate.Conclusion: Results of all validation parameter were within the limits as per International Conference on Harmonization guideline.Keywords: High performance liquid chromatography, Validation, Method development, Artemether, Accuracy, Precision.
Authors and Affiliations
Somsubhra Ghosh, Sailaja A, Ravikumar Bvv
Keywords
Related Articles
- EP ID EP605661
- DOI -
- Views 85
- Downloads 0
SELECTIVE ANTICANCER ACTIVITY OF CURCUMA XANTHORRHIZA FERMENTED JUICES
Objective: The objective of this study was to investigate the anticancer activity and toxicity of fermented juices from six Thai plants, Garcinia mangostana Linn., Tinospora crispa Linn., Litchi chinensis Sonn., Dimocarp...
ROLE OF RADIATION AS EFFECTIVE INTERVENTION IN Aβ INDUCED OXIDATIVE STRESS IN ANIMAL MODEL OF ALZHEIMER'S DISEASE
Objective: The present study was undertaken to study the therapeutic effects of low dose fractionated cranial X-irradiation on reducing the amyloid-beta (Aβ) induced oxidative stress burden in an animal model of Alzheim...
CONTROLLED VESTIBULAR STIMULATION: PHYSIOLOGICAL INTERVENTION IN DIABETES CARE
ABSTRACTObjective: The present study was aimed to assess the role of vestibular stimulation in the management of diabetes care.Methods: We carried out the present study in 83-year-old man with 20 years history of Type 2...
LETROZOLE WITH OR WITHOUT GONADOTROPIN AS A FIRST-LINE OVULATION INDUCTION IN ANOVULATORY INFERTILE WOMEN DUE TO POLYCYSTIC OVARY SYNDROME
Objectives: The objective is to evaluate the clinical outcome of using letrozole alone or with gonadotropin as first-line ovulation induction in anovulatory infertile polycystic ovary women. Methods: A prospective single...
SYNTHESIS AND CHARACTERIZATION OF SILVER NANOPARTICLES FROM MARINE BROWN SEAWEED AND ITS ANTIFUNGAL EFFICIENCY AGAINST CLINICAL FUNGAL PATHOGENS
Objectives: The aim of this study is to synthesize silver nanoparticles using the algal extract of Padina tetrastromatica and evaluate its antifungal activity against pathogenic fungus isolated from clinical samples.Resu...