AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Azelnidipine

Aditya B. Medhe, Dr. Sandhya L. Borse, Kanya V. Mhatre, Apurva D. Chavan, Tejas L. Dandgaval, Dr. Abhijeet D. Kulkarni

Page No: 116-133

DOI: 10.5281/VEREDAS.2026/V16I4/11

The new method was developed and validated by quality by design for Azelnidipine in bulk and tablet forms in a simple, sensitive, appropriate, precise, reliable, and robust way using reversephase high-performance liquid chromatography techniques. To optimize chromatographic conditions, a Central Composite Design approach was applied. Analytical separation of Azelnidipine was performed using the HPLC system with Chromeleon 7.3 Software on Agilent's Zorbax C18 column. Analysis of separated samples was accomplished using UV/visible detection at 218 nm. For the new RP-HPLC method, the mobile phase consisted of a 70:30 (v/v) mixture of Phosphate Buffer: Acetonitrile and a flow rate of 1.0 mL/min. The retention time for the target compound was 3.6 min. The new method was valid due to its linearity, accuracy, precision, specificity, robustness, and stability. The linear model fitted (r2 = 0.998), accuracy (- 2.0% RSD) and recovery (100.28%) results indicated the proposed approach had good reliability and predictability. A fast, precise, strong, and efficient QbD -empowered RP-HPLC technique of the estimation of Azalenidipine had been effectively created and validated.

Citations

APA: Aditya B. Medhe, Dr. Sandhya L. Borse, Kanya V. Mhatre, Apurva D. Chavan, Tejas L. Dandgaval, Dr. Abhijeet D. Kulkarni (2026). AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Azelnidipine. DOI: 10.5281/VEREDAS.2026/V16I4/11

AMA: Aditya B. Medhe, Dr. Sandhya L. Borse, Kanya V. Mhatre, Apurva D. Chavan, Tejas L. Dandgaval, Dr. Abhijeet D. Kulkarni. AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Azelnidipine. 2026. DOI: 10.5281/VEREDAS.2026/V16I4/11

Chicago: Aditya B. Medhe, Dr. Sandhya L. Borse, Kanya V. Mhatre, Apurva D. Chavan, Tejas L. Dandgaval, Dr. Abhijeet D. Kulkarni. "AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Azelnidipine." Published 2026. DOI: 10.5281/VEREDAS.2026/V16I4/11

IEEE: Aditya B. Medhe, Dr. Sandhya L. Borse, Kanya V. Mhatre, Apurva D. Chavan, Tejas L. Dandgaval, Dr. Abhijeet D. Kulkarni, "AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Azelnidipine," 2026, DOI: 10.5281/VEREDAS.2026/V16I4/11

ISNAD: Aditya B. Medhe, Dr. Sandhya L. Borse, Kanya V. Mhatre, Apurva D. Chavan, Tejas L. Dandgaval, Dr. Abhijeet D. Kulkarni. "AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Azelnidipine." DOI: 10.5281/VEREDAS.2026/V16I4/11

MLA: Aditya B. Medhe, Dr. Sandhya L. Borse, Kanya V. Mhatre, Apurva D. Chavan, Tejas L. Dandgaval, Dr. Abhijeet D. Kulkarni. "AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Azelnidipine." 2026, DOI: 10.5281/VEREDAS.2026/V16I4/11