Investigation on Effect of Stress on Dissolution Stability of Drug Product by Applying Thermal and NonThermal Methods of Analysis

Abstract

Aim: The aim of the research work has to development and validation of dissolution test method for Tapentadol using HPLC method, investigate the effects of stress on dissolution stability by thermal and non-thermal methods. The present research work mainly focused on the evaluation and compares the influence of accelerated-aging conditions on the drug content and in vitro dissolution stability.
 Place and duration of Study: Department of Pharmaceutical Chemistry, Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee, Nagpur (MS).
 Methodology and Results: Saturated solubility study of tapentadol were carried out using different dissolution media and different conditions such as type of dissolution medium, volume of dissolution medium and rotation speed of paddle were evaluated. Basis of it, dissolution testing were carried out on a suitably calibrated USP Apparatus II (TDT-06L) at 50 ± 1 rpm, under sink conditions in 900 mL of deaerated distilled water at 37±0.5ºC for each test and selected most optimized dissolution parameter which given maximum % release of drug. The drug release was evaluated by high-performance liquid chromatographic method. Also proposed method were validated as per ICH guidelines with respect to system suitability, linearity, precision, accuracy, range, robustness, ruggedness and solution stability parameters were evaluated and the obtained results were within the acceptable range. The stress on dissolution stability of standard powdered drug, tablet formulation and packed strip formulation were investigated by using thermal and non thermal methods. The results obtained in all stress conditions such as thermal, humidity, UV light and visible light were evaluated for drug content and drug release. The results were statistically evaluated by applying two-way ANOVA followed by post-hoc Bonferroni test and their results represented as a graphical plot.
 Conclusion: In our investigation of stress dissolution of drug it was found that Tapentadol HCl std. drug was susceptible to degradation. The tablet and packaged formulation were susceptible to photolytic degradation indicated by difference in drug content while the release was more affected under UV exposed to tablet and strip packaged formulation as compared to other stress conditions.