1Department of Quality Assurance, PIPR, Parul University, India
2K B Raval College of Pharmacy, Shertha, Gandhinagar, India
*Corresponding Author E-mail: harshadhvaryu@gmail.com
Online Published on 06 January, 2026.
In pharmaceutical field, it is often required to prepare aqueous solutions of a variety of insoluble drugs. The ability to increase the aqueous solubility can be a valuable aid for increasing the efficacy and reducing adverse effects for certain drugs. Most of quantitative analysis of poorly water-soluble drugs involves use of various organic solvents. Hydrotropic solution may be a proper choice to preclude the use of organic solvents so that a simple, accurate, novel, safe and precise method has been developed.
Selection of suitable hydrotropic agent for Metoprolol succinate and optimizing its concentration followed by development and validation of analytical method by HPLC as per ICHQ2(R1).
Development of method was accomplished using 2.5% Trisodium citrate: 2.5% Sodium acetate trihydrate (50%:50%) in water as mobile phase and Kromasil C18 as column. The flow rate was 1.0ml/min and detection at 234nm.
Linearity range of 25-150% meets correlation coefficient > 0.998. %RSD of repeatability were <2.0%. Recovery range of 50-150% of meets 98-102%.
Analytical procedure was successfully validated for Specificity, Linearity, Precision, Accuracy and System Suitability and applied for routine testing for estimation of antidiabetic drug.
USP<1225>, ICH Q2(R1), Hydrotropic Agent, Metoprolol Succinate
