DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING REVERSE-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS OF REGADENOSON FROM ITS PARENTERAL DOSAGE FORM
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2018, Vol 11, Issue 8
Abstract
Objective: The objective was to develop and validate the stability indicating reverse-phase high-performance liquid chromatography method for the quantification of potential degradation products of regadenoson (REGA) from its injectable dosage form.Methods: YMC-PAK ODS AQ, 150 mm × 4.6 mm, 3 μm composed with hydrophobic high carbon loading and a relatively hydrophilic surface chemically bonded to porous silica particles column was used with the temperature maintained at 40°C. Mobile phase A composed of 0.1% triethylamine buffer having pH 4.5 while mobile phase B is 100 % acetonitrile was used for gradient elution with 1.5 ml/min as a flow rate. The wavelength used for quantification was 245 nm and 20 μl as an injection volume. The suitability of the method has been checked and validated according to the International Council for Harmonization (ICH) guidelines for different parameters, namely, specificity, linearity, accuracy, precision, limit of quantification (LOQ), Limit of detection (LOQ), and robustness studies.Results: The resolution between REGA and its two-degradation product is >8.0 for all pairs of components. The high correlation coefficient (r2>0.990) values are for drug and all potential degradation products from LOQ to 150% of specification limits for impurities calculated based on the maximum daily dose of REGA. LOQ for the drug as well as each degradation product is <0.02% w/w. The % relative standard deviation (RSD) for precision and intermediate precision is in the range of 0.17–0.89, and % RSD for precision at LOQ is 0.86–2.35. The % RSD for robustness study is maximum 2.59.Conclusion: The developed method can quantify the specified and unknown degradation products from 0.1% in the injectable dosage form which indicates that method is sensitive. Method fulfills the ICH criteria for its different validation parameters and demonstrates that the developed analytical method is highly specific, precise, and robust and would have a great value when applied in quality control and stability studies for REGA injection.
Authors and Affiliations
Murlidhar V Zope, Rahul M Patel, Ashwinikumari Patel, Samir G Patel
Keywords
Related Articles
- EP ID EP567351
- DOI 10.22159/ajpcr.2018.v11i8.26164
- Views 142
- Downloads 0
IN VITRO ANTIBACTERIAL AND ANTIFUNGAL ACTIVITIES OF AQUEOUS AND ETHANOLIC LEAF EXTRACTS OF ACACIA AURICULIFORMIS
Objective: The present study focuses on in vitro antimicrobial properties of aqueous and ethanol leaf extract of Acacia auriculiformis tested on Gram-positive cocci, Gram-negative bacilli, multidrug-resistant (MDR) Gram-...
EVALUATION OF IN VITRO INHIBITION OF PROTON􀇧PUMP BY NANOSILVER PARTICLES SYNTHESIZED USING SEEDS OF ANETHUM GRAVEOLENS
Objective: The green synthesis of nanoparticles is gaining popularity owing to its several advantages over the chemical methods. This study reports the biosynthesis of nanosilver mediated by the extract of the seeds of A...
EVALUATION OF HYPOLIPIDEMIC ACTIVITY OF FRUIT RIND EXTRACTS OF GARCINIA GUMMIGUTTA IN DIET-INDUCED HYPERLIPIDEMIC RATS
Objective: The objective of the study was to evaluate the hypolipidemic activity of fruit rind extracts of Garcinia gummi-gutta in diet-induced hyperlipidemic rats. Methods: Hydroalcoholic extract of fruit rinds of G. g...
ANALYSIS OF HIGH DOSE AND LONG-TERM PREDNISONE THERAPY ON OSTEOCALCIN LEVELS IN CHILDREN WITH NEPHROTIC SYNDROME (STUDY AT PEDIATRIC DEPARTMENT NEPHROLOGY DIVISION OF DR. SOETOMO TEACHING HOSPITAL SURABAYA)
Objective: The objective of the study to analyze osteocalcin levels in induction and alternate phase, associated with clinical manifestation. Methods: We conducted a prospective longitudinal study. This study was subject...
MORPHOMETRIC STUDY OF PROXIMAL FEMUR AND ITS CORRELATION WITH BONE MINERAL DENSITY. A CROSS-SECTIONAL STUDY
Objective: Proximal femoral morphometries such as hip axis length (HAL), femoral neck (FN) axis length (FNAL), and FN shaft angle (FNSA) are important parameters for prediction of fracture risk. These parameters are affe...