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

Abstract View

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  

 View HTML        View PDF

Please allow Pop-Up for this website to view PDF file.

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


      Akter, S., Hossain, M. T., Sarkar, A. P., Sadikuzzaman, M., Sarkar, B. K., Saha, P., & Kundu, S. K. (2022). Development and validation of HPLC method for estimation of sitagliptin in the tablet dosage form.

2.         Punagoti, R. A., & Mourya, R. (2021). Development and validation of new RP-HPLC method for the quantitative estimation of sitagliptin phosphate in bulk and tablet dosage form. Journal of Advanced Scientific Research, 12(03 Suppl 2), 301-305.

3.         Bergman, A. J., Stevens, C., Zhou, Y., Yi, B., Laethem, M., De Smet, M., Snyder, K., Hilliard, D., Tanaka, W., Zeng, W., Tanen, M., Wang, A. Q., Chen, L., Winchell, G., Davies, M. J., Ramael, S., Wagner, J. A., & Herman, G. A. (2006). Pharmacokinetic and pharmacodynamic properties of multiple oral doses of sitagliptin, a dipeptidyl peptidase-IV inhibitor: a double-blind, randomized, placebo-controlled study in healthy male volunteers. Clinical therapeutics, 28(1), 55–72. https://doi.org/10.1016/j.clinthera.2006.01.015

4.         Lavanya, R., & Yunoos, M. (2013). Development and validation of RP-HPLC method for the estimation of sitagliptin phosphate in bulk and its tablet dosage form. Journal of Advanced Pharmacy Education and Research, 3(4-2013), 475-479.

5.         Qassas, M. K., Ameral-mardini, M., & Ghazal, H. (2015). A validated HPLC stability indicating method for the determination of sitagliptin in bulk drug substance and tablets. Int. J. Pharm. Sci. Rev. Res, 32(1), 33-194.

6.         Krishnan, B., & Mishra, K. (2020). Quality by Design based Development and Validation of RP-HPLC Method for Simultaneous Estimation of Sitagliptin and Metformin in Bulk and Pharmaceutical Dosage Forms. International Journal of Pharmaceutical Investigation, 10(4).

7.         Ramalingam, P., Bhaskar, V. U., Reddy, Y. P., & Kumar, K. V. (2014). Stability-indicating RP-HPLC method for the simultaneous determination of sitagliptin and simvastatin in tablets. Indian Journal of Pharmaceutical Sciences, 76(5), 407.

8.         Zhou, T. Y. (2011). method for the Quantitative determination of sitagliptin in rat plasma. Journal of Chinese Pharmaceutical Sciences, 20, 63-69.

9.         Rubina, R., & Gopal, R. (2015). Development and Validation of Spectrophotometric Method for Simultaneous Estimation of Gliclazide and Sitagliptin Phosphate Monohydrate in Bulk and Pharmaceutical Dosage Form. International Journal of Pharmacy and Pharmaceutical Sciences, 7(6), 372-376.

10.     Sangshetti, J. N., Deshpande, M., Zaheer, Z., Shinde, D. B., & Arote, R. (2017). Quality by design approach: Regulatory need. Arabian Journal of chemistry, 10, S3412-S3425.

11.     Gunda, R. K., Kumar, J. S., Babu, C. A., & Anjaneyulu, M. V. (2015). Formulation Development And Evaluation Of Lamotrigine Sustained Release Tablets Using 3 2 Factorial Design. Cellulose, 4, 5.

12.     Kumar, L., Reddy, M. S., Managuli, R. S., & Pai, G. (2015). Full factorial design for optimization, development and validation of HPLC method to determine valsartan in nanoparticles. Saudi Pharmaceutical Journal, 23(5), 549-555.

13.     Ravichandran, V., Shalini, S., Sundram, K. M., & Harish, R. (2010). Validation of analytical methods–strategies & importance. International Journal of Pharmacy and Pharmaceutical Sciences, 2(3), 18-22.

14.     Yahya, B. A., Bawazir, A. S., Sangshetti, J. N., Baig, S. S., & Shaikh, S. S. (2021). QbD-based development and validation of an efficient RPHPLC method for estimation of abiraterone acetate in bulk, tablet, and in-house-developed nano-formulation. Analytical chemistry letters, 11(1), 112-130.

15.     Sharma, S., Goyal, S., & Chauhan, K. (2018). A review on analytical method development and validation. International Journal of Applied Pharmaceutics, 10(6), 8-15.

 

Related Images:



Recent Images



Phytosomes: Lipid-Based Nanocarriers for Enhanced Herbal Bioavailability
A Review on Nanosponges: Versatile Carriers for Enhanced Drug Delivery
Risk-Based Matrix Approach for Determining Effort, Formality, and Documentation in Cleaning Validation
Transformation of Traditional Bajrang Lep into a Modern Polyherbal Hydrogel: Formulation and Evaluation of a Topical Anti-inflammatory Preparation
Clinical and Observational Study on Sickle Cell Disease in Akkalkuwa Region, Maharashtra
Understanding Drug Development Failures: Scientific, Financial, and Regulatory Drivers
Pluronic-Lecithin Organogels as A Novel Carrier for Dermal Delivery: A Review
Synergistic Therapeutic Potential of Elaeocarpus ganitrus and Withania somnifera in Epilepsy Management: A Comprehensive Review
Comprehensive Review of Co-Processing Technology in Pharmaceuticals
Investigation and Effective CAPA System: The Biggest Opportunities of the Investigation CAPA System & How to Fix Them

Tags


Quick Links


Latest Issues

Popular Articles