Development of analytical method validation procedure for Fidaxomicin tablet for oral suspension

Hansal Gandhi, Riddhi Trivedi*

SAL College of Pharmacy, Gujarat Technological University, Ahmedabad, Gujarat, India

Refer this article

Hansal Gandhi, Riddhi Trivedi, 2025. Development of analytical method validation procedure for Fidaxomicin tablet for oral suspension. Journal of medical pharmaceutical and allied sciences, V 14 - I 2, Pages - 005 – 013. Doi: https://doi.org/10.55522/jmpas.V14I2.6852.

ABSTRACT

Analytical procedures for oral solid dosage forms are necessary to comply various validation criteria which mainly are the accuracy, precision, specificity, robustness, and limit of detection. For the Fidaxomicin tablets for oral suspension, we have checked all these parameters to ensure the efficacy of the formulation. In this research article, all above parameters are tested in line with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and United States Food and Drug Administration (USFDA) guidelines and results are reported in a scientific manner.

Keywords:

Analytical procedures, Method validation, Fidaxomicin, Accuracy, Precision.

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