METHOD DEVELOPMENT AND VALIDATION OF LIRAGLUTIDE IN BULK AND MARKETED DOSAGE FORM BY USING RP-HPLC TECHNOLOGY Enhancing Quantitative Analysis through RP-HPLC Technology
Article Sidebar
Main Article Content
Abstract
Simple, Precise, Economical, Fast and Reliable RP-HPLC Technique has been developed for the estimation of Liraglutide in bulk and pharmaceutical dosage form. The detection was carried out by using a UV detector set at a wavelength of 245nm and 20μl sample was injected. The retention time for Liraglutide was 2.978 min. The peak obtained was symmetrical with tailing factor less than 2 and theoretical plates more than 2000. Isocratic elution at a flow rate of 1.2ml/min was employed on Inertsil ‐ Extend ‐ C18 (250 × 4.6 mm, 5 μm) HPLC column. A mobile phase comprising PHP Buffer (0.1% OPA): MeOH: ACN 50:25:25%V/V (pH 4.2) was developed. Validation experiments were performed to demonstrate linear over the concentration range of 10 ‐ 100μg/ml and get the correlation Regression (r2) 0.9996, showed good recoveries 98.95 - 101.22 %, the % RSD of Precision studies were found ˂ 2%. The method can be used for quality control assay of Liraglutide. The results were validated statistically as per ICH Q2 R1 guideline and were found to be satisfactory. The proposed methods were successfully applied for the determination of Liraglutide in commercial pharmaceutical dosage form.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
How to Cite
References
Lingvay I, Hansen T, Macura S, Marre M, Nauck MA, et al. Superior weight loss with once-weekly semaglutide versus other glucagon-like peptide-1 receptor agonists is independent of gastrointestinal adverse events. BMJ Open Diabetes Res Care 2020; 8(2):001706. DOI: 10.1136/bmjdrc-2020-001706.
Knudsen LB, Lau J. The Discovery and Development of Liraglutide and Semaglutide. Front Endocrinol (Lausanne) 2019; 10: 155. Published 2019 Apr 12. DOI: 10.3389/fendo.2019.00155.
International conference on Harmonization, Guidance for industry In; Q2A Text on validation of analytical method, Switzerland; IFPMA 1994; 1-4.
International conference on Harmonization, Guidance for industry In; Q2B Validation analytical procedures, Methodology, Switzerland; IFPMA 1996; 1-8.
Guntala Jagadeesh, et al. Development and Validation of a new robust RP-HPLC Method for the simultaneous quantitation of Semaglutide and Liraglutide in Bulk and Pharmaceutical Dosage Form. Solovyov Studies ISPU, 2023; 71(8): 544-554.
Joshna Sree, et al. A Quantitative RP-HPLC Approach for the Method Development and Validation for the Simultaneous Quantification of Semaglutide and Liraglutide in Pharmaceutical Dosage Forms. Journal of Xi’an Shiyou University, Nat Sci Edit 2022; 18: 684-693.
P.V.V. Satyanarayana, et al. Validated RP - HPLC Method for the Estimation of Liraglutide in Tablet Dosage. Int J Sci Inv Today, 2012; 1(1); 17-26.
Pedaprolu J, et al. A new stability-indicating and validated RP-HPLC method for the estimation of Liraglutide in bulk and pharmaceutical dosage forms. Eur J Anal Chem, 2017; 12(2): 31-44.
Lalitha N et al. RP-HPLC Method for Determination of Anti-Diabetic drug Liraglutide in Bulk and Tablet Formulation. Indo Am J Pharm Res 2023; 1; 1132-1141.
T. Giri et al. Establishment of stability-indicating purity method based on the stress degradation behaviour of human glucagon-like peptide-1 analog liraglutide using reverse phase-liquid chromatography. National Institute of Pharmaceutical Education and Research-Ahmedabad (Ministry of Chemicals and Fertilizers, Government of India), Gandhinagar, Gujarat 382355, India, Ind J Pharm Sci 2023; 85(4): 1068-1076.
Jhansi Naga Lakshmi Pedaprolu et al., A New Stability-Indicating and Validated RP-HPLC Method for the Estimation of Liraglutide in Bulk and Pharmaceutical Dosage Forms. Eur J Anal Chem 2017; 12(2):31-44.