Development and Validation of RP-HPLC Method for Estimation of Ticagrelor in Pharmaceutical Dosage Form and Force degradation study

Suhas S. Siddheshwar; Ajay R. Borhade; Someshwar D. Mankar; Santosh B. Dighe; Arshu P. Patel

doi:10.52756/ijerr.2024.v42.003

Authors

Suhas S. Siddheshwar Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal-Rahata, Ahmednagar-413736, Maharashtra, India https://orcid.org/0000-0002-7944-9470
Ajay R. Borhade Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal-Rahata, Ahmednagar-413736, Maharashtra, India https://orcid.org/0009-0005-9078-8114
Someshwar D. Mankar Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal-Rahata, Ahmednagar-413736, Maharashtra, India https://orcid.org/0000-0003-3991-9412
Santosh B. Dighe Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal-Rahata, Ahmednagar-413736, Maharashtra, India https://orcid.org/0000-0003-3260-2981
Arshu P. Patel Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Tal-Rahata, Ahmednagar-413736, Maharashtra, India https://orcid.org/0000-0002-3941-9453

DOI:

https://doi.org/10.52756/ijerr.2024.v42.003

Keywords:

RP-HPLC, Tablet dosage form, Ticagrelor, Validation

Abstract

Ticagrelor is a selective Adenosine diphosphate (ADP)-receptor antagonist which is prescribed in the form of tablets and acts as an oral antiplatelet for the prevention of further thrombotic events in patients with Acute coronary syndrome (ACS) and those undergoing Percutaneous coronary intervention (PCI). Therefore, accurate and reliable determination of Ticagrelor in bulk and in dosage forms is vital for clinical consideration. The objective of the method is to develop a new, simple, sensitive, accurate, and economical analytical method for the determination of assay of Ticagrelor Tablet and to perform a forced degradation study of Ticagrelor Tablet by RP-HPLC. Chromatographic separation was achieved on an UHPLC equipped with reverse phase C-18 (250 × 4.6mm, 5µ) with a mobile phase composed of acetonitrile and buffer solution (75:25) at a flow rate of 1.10 ml/min. The effluents were detected at a wavelength of 256 nm. The retention time of Ticagrelor was found to be at 3.579 min. The correlation coefficient for Ticagrelor was found to be 0.997. Recovery of Ticagrelor in the formulation was found to be 98%-102%. LOD and LOQ values of Ticagrelor were found to be 1.31 and 3.98, respectively. The method was proven to be precise (%RSD=2%), accurate (>90%), and specific for the measurement of Ticagrelor in tablets. Thus, being simple, accurate, precise, and rapid, the newly developed RP-HPLC method is recommended for the estimation of Ticagrelor in nature. Due to its high sensitivity and specificity, it is a suitable choice for identifying Ticagrelor in drugs and other products and differentiating hid similarities. However, this method can effectively be used for routine assay and stability study, which can help manage cardiovascular diseases since the quality and efficacy of Ticagrelor-containing products are significant to patients’ condition.