Abstract

Development and Validation of Simplified RP-HPLC Method for Quantification of Candesartan Cilexetil in Commercial Formulations

Author(s): Sachin Kothawade*, Rashmi Tambare, Vishal Pande, Rucha Pardeshi, Sandesh Bole, Pranaya Misar, Balireddy Keesara, Prachi Kanawade, Kanchan Jadhav, Vijaya Padwal, Amit Lunkad and Manjusha Bhange

In order to produce antihypertensive effects, Candesartan Cilexetil (CC), a candesartan inactive prodrug, was quickly converted into active candesartan after absorption in the Gastrointestinal (GI) tract. This research study describes the development and validation of an accurate, precise, repeatable, easy and speedy Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) approach for measuring CC in a formulation using reverse-phase HPLC. In this study, liquid chromatography was performed on a Zorbax SB C-18 analytical column with dimensions of 2504.6 mm, 5 m, using a mobile phase consisting of Acetonitrile (ACN) and 0.1 percent orthophosphoric acid (pH 2.5) in a ratio of 35:65 vol/vol as the mobile phase. Results were presented as mean Standard Deviation (SD). This experiment used an injection volume of 20 microliters to measure the sample at 258 nano liters per minute while using a flow rate of 1.5 microliters per minute. 4.2 minutes was determined to be the retention time for both the reference and sample drugs. There was no evidence of nonlinearity in the calibration curve for CC when the concentration ranged from 50 ppm to 160 ppm and the Regression coefficient (R2) was determined to be 0.9996. When the percentage recovery of CC was achieved, it was in the range of 98.10 percent to 98.70 percent, indicating that the present approach was very accurate. Recovery trials using Percent Relative Standard Deviation (percent RSD) with intra and inter-day accuracy were found to be less than 2 percent, demonstrating that the established procedure is repeatable. The technique was verified in accordance with the International Conference on Harmonization (ICH) requirements and may be highly recommended for regular analysis of CC due to the fact that it is the most reliable and quick methodology currently available. Despite the fact that a great deal of research has been done on calculating CC in dosage forms, this study was determined to be under green chemistry conditions, as well as being quick and inexpensive. As a result, the statistical validation of the data revealed that the suggested approach may be used to estimate the CC in commercial formulations, which is encouraging.

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