Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2024
  • Volume: 17
  • Issue: 8

Solubility Reinforcement using Binary Solvent Mixtures and its use in Development and Validation of UV-Spectrophotometric Method for Posaconazole

  • Author:
  • Tushar G. Rukari1,2,*, Prashant L. Pingale3, Chandrashekhar D. Upasani4
  • Total Page Count: 7
  • Page Number: 3700 to 3706

1Research Scholar, Department of Pharmaceutics, SNJB’s Shriman Suresh Dada Jain College of Pharmacy, Chandwad, Maharashtra, 423101, India

2Asst. Professor, Department of Pharmaceutics, Yashwantrao Bhonsale College of Pharmacy, Sawantwadi, Maharashtra, 416510, India

3Research Guide, Department of Pharmaceutics, M.S. Gosavi College of Pharmaceutical Education and Research, Vidyanagar, College Road, Nashik, 422005, India

4Research Centre Head, Department of Pharmacology, SNJB’s Shriman Suresh Dada Jain College of Pharmacy, Chandwad, Maharashtra, 423101, India

*Corresponding Author E-mail: tushar.rukari@gmail.com

Online Published on 30 April, 2025.

Abstract

To develop a method that meets the requirements as per ICH guidelines for validation and can be used as simple, specific, economical, and repeatable for routine quality control analysis of formulations containing Posaconazole.

The maximum absorbance of Posaconazole was successfully recorded using a precise 1:1 ratio of binary solvent system Methanol: Buffersolution pH 7.4 at 262nm.

After a preliminary physicochemical investigation the precipitation of the Posaconazole issue was resolved using a precise 1:1 ratio of binary solvent system Methanol: Buffersolution pH 7.4. Development and validation of the analytical method was done using the same binary solvent system. The maximum absorbance with this solvent system was found at 262nm, while the calibration curve shows a Regression coefficient (R2) of about 0.9984 for its linearity in the concentration range of 2.5 to 15µ/ml. The developed method was validated and meets the requirements as per ICH (International Conference for Harmonization) guidelines where the Limit of Detection (LOD) as well as Limit of Quantification (LOQ) were noted as 0.74µ/ml and 2.25µ/ml. Percentage recovery was within the permissible range (with a % relative standard deviation of less than 2.0).

The results from validation parameters specifically accuracy or % recovery and robustness study reveal that the developed method meets the requirements and can be used as simple, specific, economical, and repeatable for routine quality control analysis of formulations containing Posaconazole.

Keywords

Posaconazole, Validation, Spectrophotometric method, ICH Q2(R2)