Analytical Method Development and Validation of RP-HPLC Method for Estimation of Linagliptin in Bulk and Pharmaceutical Dosage Form
DOI:
https://doi.org/10.63682/jns.v14i32S.8947Keywords:
Linagliptin, RP-HPLC, antidiabetic, Acetonitrile, Validation, AccuracyAbstract
A simple, precise, and specific spectroscopy method for quantitative determination of Linagliptin in API and in pharmaceutical dosage form was developed and validated. The development was performed on a Zorbax SB Phenyl column (150 x 4.6 mm, 5 µm). The pH was adjusted to 3.2 with buffer solution: acetonitrile (75:25% v/v) at a 1.0 mL/min flow rate. Samples werelyzed using a UV-visible 2487 detector at 295 nm. The developed method complied with the system suitability study with an acceptable asymmetric factor and number of theoretical plates. The linearity was observed between 10–30 μg/mL concentrations (r² = 0.999). Method accuracy was observed as 99.7 %. The drug content was found within the acceptable limit in the intermediate precision study. The retention time was obtained at 2.73 min. This method was validated and applied to the determination of Linagliptin in pharmaceutical dosage form. (1)
Downloads
Metrics
References
Chavan Avinash, Gandhimathi R 2023. Development and Validation of Analytical Method for Linagliptin Drugs in Pharmaceutical Dosage form by RP-HPLC, IJPQA, Volume 14 Issue 1,204- 207.
Nagunath Sirigiri, Siva Subramanian N, Naveen Kumar Reddy G. 2017. Stability Indicating Method Development and Validation for Simultaneous Estimation of Linagliptin and Metformin HCl in Tablets by HPLC, Der Pharma Chemica, 9(21):100 106
Khan, G; Sahu, D and Agrawal, YP. 2011. “An HPLC method for the determination of Linagliptin in bulk drug and tablets”, Asian Journal of biochemical and Pharmaceutical Research, 1, 352-358.
Kolimi P, Shankar VK, Shettar A, Rangappa S, Repka MA, Murthy SN. Development and Validation of HPLC Method for Efinaconazole: Application to Human Nail Permeation Studies. AAPS Pharm Sci Tech. 2022;23(1):1-7
R.C. Turner et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49) JAMA (1999).
Review of Linagliptin for the Treatment of Type 2 Diabetes Mellitus. Joshua J. Neumiller PharmD, CDE, CGP.
Richter, B., Bandeira-Echtler, E., Bergerhoff, K., & Lerch, C. Emerging role of dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes. Vascular Health and Risk Management, 2008;4(4):753–768.
P Toth, P. Linagliptin: A New DPP-4 Inhibitor for the Treatment of Type 2 Diabetes Mellitus. Postgraduate Medicine, 2011;123(4):46–53.
Formulation Development and In-Vitro Evaluation of Linagliptin Transdermal Patch Using Permeability Enhancer Ram Pal, Mohammad Mujahid*, Shamim Ahmad), September – October 2023; Article No. 04, Pages: 19-28
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
Terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
