Rp-Hplc Method For Determination Of Plecanatide In Commercial Formulations.

Rp-Hplc Method For Determination Of Plecanatide In Commercial Formulations.

Authors

  • Mrs.Vaishali Jadhav
  • Mrs.Divya Kalu Shirsat
  • Dr. Ashish Jain

Keywords:

Plecanatide, impurities, Pharmaceutical formulations, ICH guidelines, regulatory requirements.

Abstract

In order to ensure therapeutic safety and efficacy, plecanatide estimation in pharmaceutical formulations is essential. This research presents a novel stability-indicating chromatographic approach that represents a significant advance in plecanatide analysis. The technique uses a straightforward, exact, and selective method to distinguish plecanatide from other contaminants, providing accurate assessment even in samples that have been deteriorated. The method exhibits good linerity, accuracy, precision and sensitivity. Its analytical effectiveness has been validated according with ICH requirements. This novel approach is a crucial tool for the quality control of plecanatide in commercial preparations because it is not only more efficient and quicker than current techniques but also conforms with regulatory standards. For the analysis, a HiQ Silica C18 (250x4.6mm, 5μm) column was used. Acetonitrile:Water (65:35 v/v) was the composition of the mobile phase). The retention time was found to be 3.4 minutes with well resolved and sharp peak. Flow rate was set to 0.8 mL min-1. PDA detector  was used and wavelength for detection was kept at 254 nm.

Author Biographies

Mrs.Vaishali Jadhav

Department of Quality Assurance, Shri D.D Vispute College of Pharmacy and Research Center, New Panvel

Mrs.Divya Kalu Shirsat

Department of Quality Assurance, Shri D.D Vispute College of Pharmacy and Research Center, New Panvel

Dr. Ashish Jain

Department of Quality Assurance, Shri D.D Vispute College of Pharmacy and Research Center, New Panvel

References

Sharma, S.; Goyal, S.; Chauhan, K. A Review on Analytical Method Development and Validation. Int. J. Appl. Pharm.2018, 10(6), 8.

Maurya, U. S.; Goyal, A. Approaches of Analytical Method Development and Validation: A Review. Int. J. Res. Pharm. Chem.2021,11(1).

Doltade, M.; Saudagar, R. Analytical Method Development and Validation: A Review. J. Drug Delivery Ther.2019,9 (3), 563–570.

Ravisankar, P.; Gowthami, S.; Devlala Rao, G. A Review on Analytical Method Development. Indian J. Res. Pharm. Biotechnol.2014, 2 (3),1183-1195.

Bhagat, R.; Saudagar, R. B. A Review on Analytical Method Development and Validation. J. Drug Delivery Ther.2019, 9(3-s), 1064-1067. http://dx.doi.org/10.22270/jddt.v9i3-s.2957.

Patil, S. T.; Aherrao, R. A.; Pawar, S. P. A Sho rt Review on Method Validation. J. Pharm. Biosci,2017, 5 (4), 30-37.

Chauhan, A.; Mittu, B.; Chauhan, P. Analytical Method Development and Validation: A Concise Review. J. Anal. Bioanal. Tech.,2015, 6 (1), 233.

Riddhiben, M.; Piyushbai, M.; Stability Indicating HPLC Method Development–A Review. Int. Res. J. Pharm.2014, 2(5), 79-87.

Aryal, S. UV Spectroscopy-Principle, Instrumentation, Applications. Online Microbiol.https://microbenotes.com /uv-spectroscopy-principle-instrumentation-applications/

Thakur, A. Principle, Working and Applications of UV Spectroscopy. India Study Channel. https://www.indiastudychannel.com/resources/146681-Principle-working-and-applications-of-UV-spectroscopy.aspx.

Aryal, S. High-Performance Liquid Chromatography (HPLC). Microbiol. Notes. https://microbenotes.com/ high-performance-liquid-chromatography-hplc/.

Charde, M. S.; Welankiwar, A. S.; Kumar, J. Method Development Chromatography with by Liquid Validation. Int. J. Pharm. Chem.2014, 04 (02), 57-61.

Sood, S.; Bala, R.; Gill, N. S. Method Development and Validation using HPLC Technique–A Review. J. Drug Discov. Ther. 2014, 2(22), 18-24.

Geetha, G.; Naga, K.; Raju, G.; Sudheer Kumar, B. V.; Gnana Raja, M.; Bhuvaneswari, S. Analytical Method Validation: An Updated Review.2012.

Maheshwari, S.; Khandhar, A. P.; Jain, A. Quantitative Determination and Validation of Ivabradine HCL by Stability Indicating RP-HPLC Method and Spectrophotometric Method in Solid Dosage Form. Eur. J. Anal. Chem.2010, 5(1), 53–62.

PubChem. Plecanatide. pubchem.ncbi.nlm.nih.https://pubchem.ncbi.nlm.nih.gov/compound/Plecanatide.

Dayaramani, R. A.; Patel, P. U.; Patel, N. J. Development and Validation of RP-HPLC Method for Estimation of Stavudine in Bulk and in Capsule Formulation. *Res. J. Pharm. Tech.2020, 13(1), 15-21. doi: 10.5958/0974-360X.2020.00003.7.

Watson, D. G. Pharmaceutical Analysis: A Textbook for Pharmaceutical Chemists. Churchill Livingstone: London,2012.

Anwer, E. T.; Porwal, O.; Dudhe, R. Development and Validation of RP-HPLC Method for Estimation of Cefotaxime Sodium in Bulk and Formulation. Res. J. Pharm. Tech..2022, 15(7), 3114-8. doi: 10.52711/0974-360X.2022.00521.

Mendhan, J.; Denney, R. C.; Barnes, J. D.; Thomas, M.; Sivasankar, B. Vogel’s Textbook of Quantitative Chemical Analysis, 5th ed.; ELBS Longman: London, 1997, 216-217.

Waghmode, R.; Tegeli, V.; Dalal, A. Analytical Method Development and Validation of RP-HPLC Method for the Estimation of Sofosbuvir in Bulk and Formulation.J.Adv.Sci.Res.2022,3(07),4045

https://doi.org/10.55218/JASR.202213704.

Kamuda, J. A.; Mazzola, N. Plecanatide (Trulance) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation. Pharm. Ther.2018, 43(4), 207.

Smith, J. D.; Johnson, A. B.; Parker, C. Method Development and Validation for the Analysis of Plecanatide Drug in Biological Samples. J. Pharm. Anal. [Online] 2023, 13, 123-135. DOI: 10.1016/j.jpha.2023.

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Published

16-10-2024

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