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Analytical Method Development And Validation Of Azelnidipine By Uv-visible

Spectroscopy

Poster · March 2024

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3 authors, including:

Allen Sushant Anant Nag

Sam Higginbottom University of Agriculture, Technology and Sciences Birla Institute of Technology, Mesra
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 Analytical Method Development And Validation
Of Azelnidipine By Uv-visible Spectroscopy

Anant Nag, P. Malairajan et al. *

Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, Mesra, Ranchi, Jharkhand
Email ID: Presenting author: Anantnag21@gmail.com; Corresponding author:- kkpradhan@bitmesra.ac.in
ABSTRACT
Azelnidipine is a new dihydropyridine calcium channel antagonist with selectively for L-type calcium channel that has recently been approved in Japan
for the treatment of patients with hypertension. The objective was to develop new UV- visible spectroscopy method for Azelnidipine which should be
rapid, precise, accurate and sensitive and validate the develop method according to ICH guidelines by the use of API and tablet formulations of
Azelnidipine by UV- visible spectroscopy. UV-Visible Spectrophotometric determination was performed with Systronics PC- based double beam
spectrophotometer 2202. A simple, Rapid, precise, accurate and sensitive UV- visible Spectroscopy method has been developed for the determination of
Azelnidipine by using methanol as a medium. The spectrum of the standard solution was run from 200-400nm range for the determination of λmax and
the λmax of Azelnidipine was found at 257nm. The absorbance of 2-14μg/ml of standard drug solution was measured at λmax 257nm. Validation
parameters such as linearity, range, LOD and LOQ, accuracy, precision and robustness were evaluated as per ICH guidelines. The proposed UV-visible
spectroscopy method and its validation according to the ICH guidelines shows that develop method is sensitive, precise, accurate and simple for the
determination of Azelnidipine API and tablet formulation.

INTRODUCTION MATERIAL & METHODS

 In the present research work, an attempt has been made to
 Azelnidipine is a lipophilic dihydropyridine
develop a Uv Visible Spectroscopy method for Azelnidipine.
calcium channel blocker antagonist.
The External Standard Method is generally used for
Dihydropyridine (DHP) calcium channel blockers
quantification analysis as assures accuracy and precision in the
are derived from the molecule dihydropyridine
quantitative analysis. A calibration curve was obtained by
and often used to reduce systemic vascular
plotting standard peak area against concentration.
resistance and arterial pressure.
 Azelnidipine API sample was gifted obtain from Ajanta
 Azelnidipine is a new and long acting
The Multifactorial Actions Of Azelnidipine Pharma. Pvt. Ltd, Aurangabad India used for this experimental
dihydropyridine derivative with calcium
work. The limit of detection and limit of quantification of the
antagonistic activity. Azelnidipine is inhibits
projected methodology was found to be 0.77 and 2.36 that is
Trans membrane Ca+2 influx through the voltage
Simple and rapid for quantification of Azelnidipine table
dependent channels of smooth muscle in vascular
formulation. The value of % assay was found to be less than
walls.
98% for this method that indicate Method is accurate and free
from the interference used in formulation.
RESULTS & DISCUSSIONS
Structure of Azelnidipine
 UV-Visible Spectroscopy analysis of Azelnidipine
was found to be less than 2% RSD according ICH
Guideline that indicate proposed method is
sensitive.
 Correlation coefficient of Linearity is 0.9826. The
value of % RSD for intra-day and Interday were
within normal range and the accuracy was found to
be normal range.

λ max of Azelnidipine (100μg/ml)

Summary of validation parameters

Intra-day Precisions
CONCLUSION
The proposed method development of UV-Visible Spectroscopy
is quite, rapid, precise, and accurate and sensitive for
Azelnidipine tablet formulation. In validation of UV-Visible
Inter day precisions Spectroscopy, it can be concluded that spectroscopic method
has been validated. All the validation parameter likes linearity,
Calibration Curve of Azelnidipine At 257 Nm
REFERENCES accuracy, precision and Robustness was found to be less than
2% RSD according ICH Guideline that indicate proposed
1. Ram, C.V.S. Therapeutic Usefulness of a Novel Calcium Channel Blocker Azelnidipine in the Treatment of Hypertension: A Narrative Review. Cardiol
Ther 11, 473–489 (2022). https://doi.org/10.1007/s40119-022-00276-4
method is sensitive. Correlation coefficient of Linearity is
2. P.S. Jain, A.J. Chaudhari, S.A. Patel, Z.N. Patel, D.T. Patel, Development and validation of the UV- Spectrophotometric method for determination of 0.9826. The value of % RSD for intra-day and Interday were
terbinafine hydrochloride in bulk and in formulation, Pharm. Methods, 2011; 2: 198–202. https://doi.org/10.4103/2229-4708.90364.
within normal range and the accuracy was found to be normal
range. The limit of detection and limit of quantification of the
ACKNOWLEDGEMENTS projected methodology was found to be 0.77 and 2.36 that is
Thank you to the department of pharmaceutical sciences and technology(bit, Mesra), my advisor Simple and rapid for quantification of Azelnidipine table
Dr. K.K.Pradhan sir and all those who have supported me furthering my research experience through feedback. formulation.

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