|
QbD Based Development and Validation of a Stability-Indicating HPLC Method for Estimating Pyrantel Pamoate in Bulk and Formulation
|
|
| Author:
|
PRAMOD DONGARE, VISHNU GUPTA, AMIT KASABE
|
| Abstract:
|
A Quality by Design (QbD) based stability-indicating High-Performance Liquid Chromatography (HPLC) method was developed and validated for the estimation of Pyrantel Pamoate in both bulk and tablet formulations. The method was optimized to ensure simplicity, accuracy, and precision, meeting the rigorous standards required for pharmaceutical analysis. The retention time for Pyrantel Pamoate was found to be 2.514 minutes, providing a rapid analysis suitable for high-throughput testing. The %Relative Standard Deviation (%RSD) was calculated at 1.35%, indicating excellent precision and repeatability. The %Recovery of Pyrantel Pamoate was determined to be 85.83%, demonstrating high accuracy. Sensitivity of the method was confirmed with Limit of Detection (LOD) and Limit of Quantification (LOQ) values of 0.135 ppm and 0.367 ppm, respectively. The regression equation derived for Pyrantel Pamoate was y = 131019x - 656634, which reflects the method’s reliability for accurate quantification. The reduced retention time and overall decrease in run time make this method both simple and economical, offering significant advantages for routine quality control testing in the pharmaceutical industry. The developed method is robust, validated, and suitable for stability testing and regulatory compliance.
|
| Keyword:
|
Quality by Design (QbD), Stability-indicating HPLC, Pyrantel Pamoate, Tablet Dosage Form, Method Validation, Stability Testing, High-Performance Liquid Chromatography (HPLC).
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2025.17.01.002
|
| Download:
|
Request For Article
|
|
|