Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
Abstract
Validated Stability Indicating Method for Estimation of Methoxsalen in Its Formulation By HPLC Analysis
Author(s): Saumayata Khobragade, Apurva Wasnik, Krishna Gupta* and Milind UmekarAim: The current study concentrates on the kinetics and behaviour of Methoxsalen in solution state drug degradation.
Background: Information from stress testing can subsequently be utilized to create manufacturing procedures or choose the best packaging. It also aids in the preparation of reference data for degradation products that are unknown.
Stress testing is frequently repeated as manufacturing techniques, product composition and analytical procedures are modified and brought to a more final condition, even though pre-formulation work is a necessary component of early phase drug development.
Objective: The study’s design involves selecting an RP-HPLC method for drug estimation followed by assessments of the kinetics of drug degradation, shelf-life estimation and validation of the method.
Methods: Methoxsalen was analyzed for stress degradation in tablet dosage form using the Shimadzu HPLC series 1100. The Agilent ZORBAX SB-C8 (4.6 cm × 150 mm) (5 μm) column was used for the analysis, with acetonitrile:1.28 mM phosphate buffer (pH 5.0) in a ratio of 60:40 v/v as the mobile phase. The analysis was carried out at the 248 nm wavelength, with a flow rate of 1.0 ml/min at which the drug showed a sharp peak. With a 20 μl injection volume, the isocratic pump mode was used for the analysis. The mobile phase was used as diluent. Over the concentration range of 2 to 10 μg/ml, the proposed technique was proved to be linear. The analysis was carried out by placing the standard in an oven at 50ºC for intervals of 30, 60, 90, 120, 150 and 180 minutes with acidic, alkaline, oxidative hydrolytic solutions and for thermal degradation the standard taken in oven at 50ºC for 48 hours.
Results: The results were found to be highly susceptible in acid, alkaline, oxidative hydrolysis and at higher temperature. The order and kinetics of degradation study was calculated from the result obtained.
Conclusion: The proposed method was successfully used for its assay, drug degradation (stress testing) and degradation kinetics in solution state since it was shown to be specific, selective and robust.
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