A NEW STABILITY INDICATING UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DULOXETINE AND MECOBALAMIN IN BULK AND IN ITS DOSAGE FORMS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 1
Abstract
Objective: The objective of the work is to develop and validate a stability indicating, new, simple, highly sensitive RP-UPLC method for simultaneous estimation of Duloxetine and Mecobalamin in bulk and in its dosage forms. Methods: The Method was developed and excellent chromatographic separation was obtained on a reversed-phase Acquity UPLC BEH C18 (1.0 × 100 mm, 1.7 µm) column using an isocratic elution mode by the mobile phase using Methanol: Water (55:45). The flow rate of the mobile phase was 1.0mL/min and the total run time was 10 minutes. UV-Spectroscopic detection at a wavelength of 320 nm was performed and the column oven temperature was maintained at 400C. The analytical procedure was validated by assessing the specificity, linearity, precision, robustness, ruggedness, limit of detection, limit of quantification and accuracy as per ICH guidelines.Results: The retention times in the standard solution having the concentration of 3 μg/ml and 75 μg/ml of Duloxetine & Mecobalamin were found to be around 4.320 and 5.320 min respectively. The percentage purity values are 99.71 % w/v and 99.02% w/v. Calibration plots were linear (r2 > 0.999) over the concentration range of 1.5 – 5.25 μg/ml and 37.5 – 131.25 μg/ml, the percentage recovery was found to be 99.74% and 99.82% for Duloxetine & Mecobalamin respectively. %RSD for system precision, method precision, robustness and ruggedness was found to be with in 2. The LOD 0.04791 µg/mL for Duloxetine and 0.4496 µg/mL for Mecobalamin. The LOQ was found to be 0.1452 µg/mL for Duloxetine and 1.3625 µg/mL for Mecobalamin. Conclusion: The method represents a fast analytical procedure for the simultaneous quantification of Duloxetine & Mecobalamin. The developed method requires lesser analysis time and less mobile phase consumption. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that the method is specific, rapid, reliable, accurate, robust and reproducible. The method is amenable to the routine analysis of large numbers of samples with good precision and accuracy. The most striking feature of this method is its simplicity and rapidity, non-requiring-consuming sample preparation such as extraction with solvents, heating, degassing which are needed for HPLC procedure.
Authors and Affiliations
Y. Ismail, K. B. Chandrasekhar, V. Gunasekaran
Keywords
Related Articles
- EP ID EP579203
- DOI -
- Views 84
- Downloads 0
SOLUBILIZATION OF CELECOXIB USING ORGANIC COSOLVENT AND NONIONIC SURFACTANTS OPTIMIZED BY EXPERIMENTAL DESIGN
Objective: The solubility of drug substances in water is one of the major factors taken into account in the formulation of oral solutions and parenteral forms. The present study aims to evaluate the utility of a mixture...
MICROORGANISMS AS CHEMICAL FACTORIES FOR ISOLATION OF META-BOLOMES FROM MESOPHILIC SOIL
Objective: To investigate the micro-flora of the mesophilic soil of Rajasthan for isolation of novel compounds having antibacterial potentials.Methods: In present experiments, bacterial colonies were isolated from four d...
A CASE REPORT ON ISOLATED HEMATURIA WITH ANEMIA DUE TO SCHISTOSOMA HAEMATOBIUM
An unsual case in India was reported with an Isolated Hematuria with Anemia due to Schistosoma Haematobium. A male North African patient aged with 22 years admitted in hospital in Hyderabad with chief complaints of hemat...
ANTIBACTERIAL ACTIVITY OF PLANT BIOSURFACTANT EXTRACT FROM SAPINDUS MUKOROSSI AND IN SILICO EVALUATION OF ITS BIOACTIVITY
Objective: Natural biosurfactants can replace synthetic surfactants and find applications in cosmetic products. Saponin extracts from Sapindus mukorossi fruits have emulsifying properties and have traditionally been used...
IN VITRO ANTIPLASMODIAL ACTIVITYOF ETHANOL EXTRACTS OF BORNEO MEDICINAL PLANTS (HYDROLEASPINOSA, AMPELOCISSUSRUBIGINOSA, URARIA CRINITE, ANGIOPTERISEVECTA)
Objective: The efforts to obtain new antimalarial medicine were among others to explore and to develop both natural substances and synthetic compounds whose activities have been established. An in vitro antiplasmodial ac...