Development and Validation of RP-HPLC Method for Estimation Ertugliflozin in Its Bulk and Tablet Dosage Form

Authors

  • Jayesh Ahirrao Research Scholar, Department of Pharmacology, R.G. Sapkal College of Pharmacy, Nashik, Maharashtra, India
  • R. S. Bachhav Associate Professor, Department of Pharmacology, R.G. Sapkal College of Pharmacy, Nashik, Maharashtra, India

Keywords:

RP-HPLC, Ertugliflozin, Antidiabetic, Development, Validation

Abstract

Background: This study developed and validated a new, sensitive, appropriate, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for determining safinamide in bulk medication and tablet formulations. An HPLC procedure using a UV detector and the Openlab EZchrome workstation programme was used to separate the samples, as well as a Kromasil C18 (250 mm × 4.6 mm i.d.) 5 μm. At a flow rate of 1.0 mL/min, methanol and buffer (70:30 percent v/v) were pumped and detected at 223 nm. Result: The new RP-HPLC method gave a satisfactory retention time of 7.95 min for ertugliflozin, which was optimised by trial and error. A correlation coefficient was used to verify the linearity of the established approach (r2) of 0.99995 over the concentration range of 2.00–30.00 ug/mL. The percentage RSD for the method's precision was found to be less than 2.0 percent. The percentage recoveries were discovered to be between 98.56 and 100.90%. 0.37 ug/mL and 1.12 ug/mL The LOD and LOQ, respectively, were discovered. Conclusion: The newly built and validated RP-HPLC technology saves time and effort can be used in the industry for routine quality control/analysis of bulk drug and marketed ertugliflozin products.

References

International Diabetes Federation (2019): Diabetes facts & figures (LAST UPDATE: 09/12/2021). Available online at: https://idf.org/aboutdiabetes/what-is-diabetes/facts-figures.html

Rang HP, Dale MM, Ritter JM, Flower RJ and Henderson G (2012): Rang and Dale's Pharmacology. Edinburgh, Churchill Livingstone, 7th Edn, pp 377–383.

Katzung BG, Masters SB, Trevor AJ (2015) Basic and clinical pharmacology. 13th Edn. McGraw Hill Medical, New York, pp 736–742

Das, SK, Elbein SC,: The genetic basis of type 2 diabetes. Cell Science: 2006: 2 (4): 100–131.

Drug Bank. Ertugliflozin (Updated at February 20, 2022 20: 42). Available online at: https://go.drugbank.com/drugs/DB11827

Malviya, R., Bansal, V., Pal, O.P., & Sharma, P.K. High performance liquid chromatography: a short review. Journal of global pharma technology, 2010: 2 (5), 22–26.

Kazakevich, Y.V., & Lobrutto, R. (2007). HPLC for pharmaceutical scientists. Wiley-Interscience; 1st edition (February 6, 2007).

Laboratory Info. High Performance Liquid Chromatography (HPLC) : Principle, Types, Instrumentation and Applications By Editorial Team (January 23, 2022). Available online at: https://laboratoryinfo.com/hplc/

Margaret E. Lacourse, William R. LaCourse (2017) “CHAPTER 17-General instrumentation in HPLC” University of Maryland, Baltimore County, MD, United States, Liquid Chromatography (Second Edition) Fundamentals and instrumentations, 417–429.

Sabir, A.M. HPLC method development and validation-a review. International Research Journal of Pharmacy, 2013: 4 (4), 39–46.

Sangshetti, J.N., Deshpande, M., Zaheer, Z., Shinde, D.B., & Arote, R. Quality by design approach: Regulatory need. Arabian Journal of chemistry, 2017: 10 (Supplement 2): S3412–S3425.

International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use ich harmonized tripartite guideline validation of analytical procedures: text and methodology Q2 (R1) Validation. https://www.ich.org/page/quality

guidelines

Pendbhaje N.S. Jamdhade A.A., Pathan S.M., Nirmal R.V.A Review on Quantification of Brexpiprazole in Its Bulk and Pharmaceutical Dosage Form by Various Analytical Methods. International Journal of Pharmaceutical Research and Applications 2021: 6: 1118–1132

Vidushi, Y., & Meenakshi, B. A review on HPLC method development and validation. Res J Life Sci, Bioinform, Pharm Chem Sci. 2017: 2 (6), 178.

Nilesh S. Pendhbaje, Rupali V. Nirmal, Ashwini A. Jamdhade, Shain M. Pathan. (2021); Method Development and Validation by HPLC: A Brief Review. Research & Reviews: A Journal of Pharmaceutical Science; 12 (1): 27–39p.

Mukthi Thammana, (2016); A Review on High Performance Liquid Chromatography (HPLC), Research & Reviews: Journal of Pharmaceutical Analysis, 5 (2). 22–28.

Kasture, A. V., & Ramteke, M. Simultaneous UV-spectrophotometric method for the estimation of atenolol and amlodipine besylate in combined dosage form. Indian journal of pharmaceutical sciences, 2006, 68 (3): 394–396

Barman RK, Islam MA, Ahmed M, Ibne Wahed MI, Islam R, Khan A, Hossain MB, Rahman BM. (2017), Simultaneous high-performance liquid chromatographic determination of atenolol and amlodipine in pharmaceutical-dosage form. Pak J Pharm Sci. xOct; 20 (4): 274–9. PMID: 17604248.

Downloads

Published

2022-03-23

Issue

Vol. 9 No. 1 (2022)

Section

Research Article

License

Declaration and Copyright Transfer Form

(to be completed by authors)

I/ We, the undersigned author(s) of the submitted manuscript, hereby declare, that the above manuscript which is submitted for publication in the STM Journals(s), is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere.

  • I/We will not withdraw the manuscript after 1 week of submission as I have read the Author Guidelines and will adhere to the guidelines.
  • I/We Author(s ) have niether given nor will give this manuscript elsewhere for publishing after submitting in STM Journal(s).
  • I/ We have read the original version of the manuscript and am/ are responsible for the thought contents embodied in it. The work dealt in the manuscript is my/ our own, and my/ our individual contribution to this work is significant enough to qualify for authorship.
  •  I/We also agree to the authorship of the article in the following order:

Author’s name                                    

 

1. ________________

2. ________________

3. ________________

4. ________________

 

We  Author(s) tick this box and would request you to consider it as our signature as we agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal.