DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF VALSARTAN
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 8
Abstract
Objective: A stability indicating RP-HPLC method was developed and validated for the determination of Valsartan using Telmisartan (10 µg/ml) as the internal standard.Methods: In this procedure Phenomenex ODS C-18(250×4.6 mm, packed with 5 micron) column was used with a new mobile phase consisting of methanol: acetonitrile: water (70:15:15 v/v) and the pH was adjusted to 3 by 0.1% glacial acetic acid with a flow rate of 1 ml/min. The eluents were monitored at 249 nm. Valsartan was subjected to stress conditions including hydrolytic degradation in acidic, basic and neutral conditions, oxidation, photolytic, UV degradation and thermal degradation.Results: Linearity was obtained in the concentration range of 10-90 µg/ml (R2 =0.999) and with a regression equation y=0.074x+0.005. The LOD and LOQ values were 0.261 and 0.791 µg/ml respectively. The drug had shown promising degradation in the acidic, basic, neutral, thermal and oxidative stress conditions.Conclusion: The method was validated for accuracy, precision, linearity, specificity and robustness and revealed that it is specific, accurate, rapid, precise, reliable and reproducible enough to analyze commercial dosage forms as per ICH guidelines.
Authors and Affiliations
K. K. Pradhan, U. S. Mishra
Keywords
Related Articles
- EP ID EP578240
- DOI -
- Views 87
- Downloads 0
OPTIMIZATION OF PROCESS PARAMETERS FOR THE PRODUCTION OF ANTIBACTERIAL COMPOUND BY A NEWLY ISOLATED NOCARDIA CYRIACIGEORGICA, KD-15 STRAIN FROM KAZIRANGA NATIONAL PARK OF NORTH EAST INDIA
Objective: An attempt has been made to evaluate the optimal cultural conditions for obtaining high yields of bioactive metabolites.Methods: A strain of actinobacteria was isolated from the soil sample of Kaziranga Nation...
METHOTREXATE FAST DISINTEGRATING TABLET AS A DOSAGE FORM FOR DYSPHAGIA PATIENTS
Objective: The objective of the present study was to develop, optimize and evaluate fast disintegrating tablet (FDT) of methotrexate (MTX) as a dosage form for dysphagia patients with a view to enhance patient compliance...
STUDIES ON ANTIMICROBIAL AND ANTIOXIDANT PROPERTIES OF LEAF EXTRACTS OF SYZYGIUM ALTERNIFOLIUM (WT.) WALP
Objective: To study the antimicrobial and antioxidant properties of Syzygium alternifolium (SA) leaf extracts by using in vitro methods.Methods: Hexane (HE), ethyl acetate (EAE), ethanol (EE) and water (WE) extracts of S...
ANTIHYPERGLYCEMIC, ANTIOXIDANT, AND PANCREAS REGENERATION ACTIVITIES OF BLACK CUMIN (NIGELLA SATIVA L.) SEEDS ETHANOL EXTRACT IN ALLOXAN-INDUCED DIABETIC RATS
Objective: The goal of this study was to determine the antihyperglycemic, antioxidant as well as pancreas regeneration effects of ethanol extracts of Nigella sativa L. seeds in alloxan-induced diabetic rats.Methods: The...
A RAPID, SENSITIVE AND VALIDATED ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY AND TANDEM MASS SPECTROMETRY METHOD FOR DETERMINATION OF PAROMOMYCIN IN MICE PLASMA: APPLICATION TO PHARMACOKINETIC STUDY
Objective: To develop and validate simple, sensitive, accurate and selective UPLC-MS/MS method for quantification of paromomycin (PARO) in mice plasma.Methods: Precipitation method was used for the extraction of plasma s...