61
Drug Delivery Letters
Send Orders for Reprints to
[email protected] Drug Delivery Letters, 2018, 8, 61-71
RESEARCH ARTICLE ISSN: 2210-3031 eISSN: 2210-304X
Development and Validation of a Discriminative Dissolution Method for the Quantification of Simvastatin in Different Pharmaceutical Formulations BENTHAM SCIENCE
Madhu Verma1,2*, Arun Nanda3 and Yatendra Kumar1 1
I.T.S College of Pharmacy Muradnagar, Ghaziabad, Uttar Pradesh, India; 2Dr. A.P.J. Abdul Kalam Technical University, Uttar Pradesh, Lucknow, India; 3Department of Pharmaceutical Sciences, M.D. University, Rohtak, Haryana, India Abstract: Background and Objectives: The aim of present research work was to develop and validate a discriminative dissolution method in order to quantify simvastatin (SIM) in various pharmaceutical preparations using High-Performance Liquid Chromatography (HPLC) and ultraviolet spectrophotometry (UV).
ARTICLE HISTORY Received: June 23, 2017 Revised: October 07, 2017 Accepted: October 25, 2017 DOI: 10.2174/2210303107666171101162757
Methods: The dissolution test was performed according to standard procedures by varying the concentration of Sodium Dodecyl Sulphate (SDS) in dissolution medium (pH 7.0 sodium phosphate buffer) in order to discriminate the impact of surfactant on dissolution rate enhancement of drug in various formulations. The aforementioned dissolution method was validated for linearity, specificity, accuracy, precision and robustness as per the ICH guidelines using HPLC and UV method. Results of dissolution test were analysed by HPLC and UV and statistically compared (P≤ 0.05) to select the best method for estimation of simvastatin in various formulations in developed medium. Results: 0.1 % SDS in dissolution medium was optimized as this concentration was able to display the actual effect of formulation on dissolution rate of drug. All results of validation parameters of developed dissolution medium were found to be satisfactory and in acceptable range for both analytical methods. Linearity was found to be 4 -60 µg/mL and 2 -16 µg/ml for HPLC and UV methods, respectively. The low value of RSD (
