METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF GEMCITABINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2011, Vol 1, Issue 5
Abstract
A simple and precise, rapid and accurate RP-HPLC method has been developed and validated for the determination of gemcitabine hydrochloride in pharmaceutical dosage forms. The chromatographic separation was achieved on kromasil stainless column (150 X 4.6 mm, 5.0 μ particle size) using acetonitrile : water (40 : 60), flow rate 1.0 mL/min. The analyte was monitored using UV-Visible detector at 270 nm. The retention time of the drug was 4.093 min for gemcitabine hydrochloride. The proposed method was found to have linearity in the concentration range 80-120 μg/mL with correlation coefficient of r2 = 0.999. The method was validated for linearity, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines.
Authors and Affiliations
R. MURALI KRISHNA, M. RAMESH, T. SIVA KUMAR
Keywords
Related Articles
- EP ID EP221902
- DOI -
- Views 96
- Downloads 0
CORRELATION BETWEEN SERUM ZINC, INSULIN AND C-PEPTIDE IN PATIENTS OF TYPE 2 DM IN A TERTIARY HOSPITAL IN NORTH INDIA
Zinc has been reported to be involved in the synthesis and release of insulin and C-peptide from the beta cells of pancreas. The possibility of a correlation between these parameters needs to be explored, specially with...
DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DACLATASVIR AND SOFOSBUVIR IN DRUG PRODUCT BY RP-HPLC
New Analytical method was developed for the estimation of Daclatasvir and Sofosbuvir in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Phenyl XDB 250*4.6mm) at ambient t...
Design and Evaluation of Extended Release Capsules of Acetazolamide Using Eudragit RS100 And Eudragit RL100
Utilizing the concept of incorporating drug in to the polymer matrices and extend the drug release for prolong period of time, an attempt was made to design and evaluate extended release capsules of acetazolamide using e...
A CASE SERIES ON AMLODIPINE INDUCED EDEMA
Hypertension is one of the most common clinical conditions encountered by the physicians. There are wide ranges of medications available for treatment of hypertension, in which Calcium Channel Blockers (CCBs) are one of...
Evaluation of Heteropogon contortus (L.) Beauv. Methanolic extract for Mast cell, Cell Membrane and free radical stabilization
Methanolic extract of Heteropogon contortus (L.) Beauv was screened for mast cell stabilization (in vitro anti-histaminic) and membrane stabilization (in vitro anti-inflammatory) effects. Extracts was also evaluated for...