International Journal of Research in Pharmacy and Allied Science

ISSN: 2583-6544   |  Issues per year: Monthly  |   Indexed In: Google Scholar, CORE, ScienceOpen, Researchgate

ISSN:2583-6544

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Quality by Design Based Analytical Method Development and Validation of Sitagliptin Phosphate by RP-HPLC

Author(s): Syed Aslam Hamid*1, Pallavi Patharkar2, Umar Attar3, Shaikh Md Moiz4, Mohd Shoeb Nawaz5

Email(s): Email ID Not Available

Address:

    Dr.Vedprakash Patil Pharmacy College Aurangabad, Maharashtra.

Published In:   Volume - 4,      Issue - 7,     Year - 2025

DOI: https://doi.org/10.71431/IJRPAS.2025.4701  

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ABSTRACT:
The proposed RP- HPLC method using QbD approach provides simple accurate, and reproducible quality analysis for determination of Sitagliptin phosphate. 32 factorial design were used. study interaction of 2 factors were selected as dependent variables i.e mobile phase composition and flow rate and independent variables i.e retention time and tailing factor were evaluated through the runs in design. The chromatographic method with C-18 column, PDA detector, 70:30 (%v/v) methanol : water as mobile phase with flow rate of 1ml/min at wavelength of 267nm. The method is validated in compliance with ICH guideline and validation parameters was studied and performed. All the results were within the specification. The Quality by Design approach has been successfully used to develop RP-HPLC method for Sitagliptin phosphate. All key aspect of QbD were tried to be implemented in study.

Keywords:

Cite this article:
Syed Aslam Hamid*, Pallavi Patharkar, Umar Attar, Shaikh Md Moiz, Mohd Shoeb Nawaz. Quality by Design Based Analytical Method Development and Validation of Sitagliptin Phosphate by RP-HPLC. IJRPAS, July 2025; 4 (6): 1-12.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.4701


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