Simultaneous Estimation of Azilsartan and Cilnidipine in Bulk by Rp-HPLC and Assessment of Its Applicability in Marketed Tablet Dosage Form

Abstract

Objective: This study aims to build up the RP-HPLC process for Azilsartan and Cilnidipine and authenticate the RP-HPLC process according to ICH validation code Q2R1. Methods: System suitability testing was performed to discover the qualifying criterion of the method by injecting the identical standard solution of Azilsartan 40μg/ml and Cilnidipine 10μg/ml in mixture/combination in subsequent optimized chromatographic conditions and the chromatogram was recorded. Moreover, the planned method was validated as per ICH guideline Q2R1 for the following parameters: linearity and range, precision, accuracy, robustness, and determined % recovery. Results: The outcomes of %RSD for retention time and peak area were found to be 0.65 and 1.32 for Azilsartan and 0.85 and 1.90 for Cilnidipine. The correlation coefficient, y-intercept, slope of the regression line were 0.9996,-1127.1, 3313.9, and 0.9993, 1460.2, 2876.4 for Azilsartan and Cilnidipine, respectively. Moreover, the range of this method was observed to be 40-240μg/ml and 10-60 μg/ml for Azilsartan and Cilnidipine, standard concentrations respectively. The % RSD achieved for precision (repeatability) was observed in the range of 1.57 to 2.43 for Azilsartan and 0.70 to 1.88 for Cilnidipine. The % accuracy was found in the range of 96.96 to 101.92% w/w for Azilsartan and 99.19 to101.96%w/w for Cilnidipine. The percent recovery values achieved for Azilsartan were in the range of 99.87 to 106.39% w/w and for Cilnidipine in the range of 94.51 to 105.96% w/w. Conclusion: The author concludes that the simultaneous estimation of Azilsartan and Cilnidipine with predefined objectives was successfully achieved. Moreover, the method was found to be steadfast for the quantification of Azilsartan and Cilnidipine in marketed tablet dosage forms.

Quality Control Assay of Two Antihypertensive Representatives Using Rp-HPLC Based Methodology: Stress Assessment on Antihypertensive Representatives

“…The peak response, plate count, resolution, and tailing symmetry are measured and summarized in table 4. Swati and Anna (2022) reported the RP-HPLC method for quality control analysis of AZIL and CLIN blend in marketed formulations [28]. Riddhi and Satish quantified AZIL and CLIN blend in mixtures developed at lab using spectrophotometry [25].…”

“…Riddhi and Satish quantified AZIL and CLIN blend in mixtures developed at lab using spectrophotometry [25]. It was discovered that the Swati and Anna method [28] had an excessive retention time, which increased the time for analysis and the cost of study. Riddhi and Satish [25] did not extend their approach to formulations, nor did they conduct degradation experiments on AZIL and CLIN.…”

AQbD-based stability indicating development and validation of azilsartan medoxomil and cilnidipine by UPLC method

“…Only a few approaches are described in the literature for the estimation of AZL and CIL (Andhalea and Nikalje, 2022; O n l i n e F i r s t Jani andPatel, 2018a, 2018b;Jena et al, 2021;Solanki et al, 2022). However, several high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectroscopy techniques for estimating AZL and CIL alone or combined with other drugs are reported (Desai and Nikalje, 2021;Deshmukh et al, 2020;Ghante et al, 2019;Kumar and Begum, 2019;Rathod et al, 2018;Ruhina and Mamatha, 2017;Soliman et al, 2019;Surwade and Saudagar, 2015;Vyas et al, 2019).…”

The Development and Validation of Fast and Robust Stability Indicating RP-HPLC Method for Simultaneous Estimation of Azilsartan Medoxomil and Cilnidipine in Pharmaceutical Dosage Form

“…3 It is reported officially in Indian Pharmacopoeia (IP)-2018. 4 Literature study revealed that the analytical techniques like HPTLC, [5][6] HPLC, [7][8] UVspectrophotometry, 9,10 LC/MS-MS [11][12] methods have been presented for determination of Azilsartan medoxomil and Cilnidipine as a single, while for the combination of Azilsartan medoxomil and Cilnidipine method is available on UV-spectroscopy 13 and HPLC, 14 there is no article related to Stability Indicating HPLC Assay method to quantify Azilsartan medoxomil and Cilnidipine in bulk has ever been mentioned within literature referred. The primary goal of this project was to produce a specific, accurate, and reproducible stability indicating HPLC methods for determination of Azilsartan medoxomil and Cilnidipine as stated in the ICH guidelines.…”