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This is a Quantitative Study study.

September 28, 2025

Stability Indicating RP-UPLC Method for the Simultaneous Estimation of Telmisaran and Azelnidipine in bulk and its Pharmaceutical Dosage Form

Key Points

The RP-UPLC method achieved a recovery rate of 99.47% for telmisartan and 99.17% for azelnidipine, confirming its accuracy.
Linearity for both drugs was established in a range of 20-60μg/ml for telmisartan and 4-8μg/ml for azelnidipine, indicating robust detection capabilities.
Validation followed ICH guidelines, ensuring the method's reliability and suitability for pharmaceutical applications.
This method's environmental friendliness was highlighted by its efficient solvent use and reduced waste generation during analysis.

Abstract

Stability indicating RP-UPLC method for the simultaneous estimation of TEL and AZEL in bulk and its pharmaceutical dosage form. In RP-UPLC method, chromatographic separation was achieved using C18 column (100 × 2.1mm, 1. 7µm) and Water-Methanol-FA (70: 30: 0.1) as mobile phase at flow rate of 0.4ml/min with detection wavelength of 243 nm. The linearity of both TEL and AZEL were found in the range of 20-60μg/ml and 4-8μg/ml. Retention time in RP-UPLC method were found to be 1.63 min, 1.15min for TEL and AZEL respectively. The % recovery were found to be 99.47±99.88 for TEL and 99.17±100.20% for AZEL. The proposed method was validated as per ICH guidelines and successfully applied for the determination of drugs in pharmaceutical formulation. This evaluation supported the method’s environmental friendliness regarding solvent usage, chemical substances, energy consumption, and waste generation.

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