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

Authors

K. V. L. D. SPANDANA Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, India https://orcid.org/0000-0002-6772-7242
N. J. P. SUBHASHINI Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, India

DOI:

https://doi.org/10.22159/ijap.2022v14i1.43321

Keywords:

Telmisartan, Azelnidipine, Hypertension, Stability investigation, HPLC

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 NaH₂PO₄solution (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.

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