TELMISARTAN AND AZELNIDIPINE QUANTIFICATION EMPLOYING HPLC STRATAGEM; STABILITY INVESTIGATION ON TELMISARTAN AND AZELNIDIPINE

K V L D Spandana,N J P Subhashini

doi:10.22159/ijap.2022v14i1.43321

Abstract

Objective: The focus of our research was to create a fairly sensitive HPLC stratagem for determining telmisartan (TLM) and azelnidipine (AEL) in bulk and tablet types. Methods: Analysis of TLM and AEL was performed on a “C18 Kromasil stationary column (5 µm, 250 mm × 4.6 mm)”. The mobile phase was made of 0.1M NaH2PO4 solution (pH 3.5) and methanol at a comparative volume ratio of 50% each. The analysis of TLM and AEL was isocratic, with the flow velocity adjusted at 1.0 ml/min and indeed, the TLM and AEL analysis was done at 256 nm using a PDA device sensor. TLM and AEL were stressed with acid, peroxide, dry heat, alkali, and sunlight-induced settings. Results: The retention/elution periods for the TLM and AEL were observed at 2.225 min and 3.178 min, respectively. The HPLC stratagem developed have a straight-line relation with relative concentrations in the ranges of 20-60 µg/ml for TLM and 4-12 µg/ml for AEL. The LOQ’s for TLM and AEL were 0.2516 μg/ml and 0.0871 μg/ml, respectively. The validation investigational findings done for TLM and AEL with the established sensitive HPLC stratagem were passed out in conformity with the ICH standards. Conclusion: The established sensitive HPLC stratagem was shown as competent for the quality check of bulk samples of TLM and AEL throughout batch release as well as in the course of TLM and AEL stability investigations.

Highlights

Telmisartan (TLM), fig. 1, is a blocker for angiotensin II receptor with remarkable pharmacologic qualities, including that of the greatest half-life of all blockers of angiotensin II receptors
Under the projected HPLC evaluation conditions, the Rt’s for TLM and AEL were observed at 2.225 min and 3.178 min, respectively, as made known in fig. 2
The increasing usage of TML and AEL for hypertension treatment has attracted our interest in developing a sensitive HPLC tool for evaluating TLM and AEL in bulk and tablet varieties

Summary

Introduction

Telmisartan (TLM), fig. 1, is a blocker for angiotensin II receptor with remarkable pharmacologic qualities, including that of the greatest half-life of all blockers of angiotensin II receptors. 1, is a blocker for angiotensin II receptor with remarkable pharmacologic qualities, including that of the greatest half-life of all blockers of angiotensin II receptors. This results in a considerable and long-lasting decrease in blood pressure of up to 24 h [1,2,3]. Hypertension sufferers are prescribed with the mix of TLM plus AEL. The combo of TLM and AEL regulates blood pressure among hypertension individuals while simultaneously enhancing oxygen circulation in the body, barring the risk of heart-related chest discomfort [7]. TLM with AEL are accessible in tablet formulations with strength of 80 mg and 8 mg of TLM as well as AEL TLM-40 mg with AEL-8 mg, respectively

Methods

Results

Discussion

Conclusion