Author(s): Swapnali Suresh Zurange, Subodh Anil Gangurde

Email(s): swapnalizurange1988@gmail.com

DOI: 10.52711/0974-360X.2025.00685   

Address: Swapnali Suresh Zurange, Subodh Anil Gangurde
School of Pharmaceutical Sciences, Sandip University, Nashik, Maharashtra, India.
*Corresponding Author

Published In:   Volume - 18,      Issue - 10,     Year - 2025


ABSTRACT:
Objective: The current work intended to build a robust, precise, accurate, and specific HPLC method for the measurement of Ivabradine in tablet dosage form and in bulk, using an advanced analytical techniques. Materials and Methods: Both perception and head part examination were used to control the basic bounds. In this investigation, an enhanced fluid chromatography method that may be used for the evaluation of Ivabradine HCL was developed through the use of the Quality by Design approach. The method was developed using the C18 segment and a portable stage that contained 0.1 M potassium dihydrogen orthophosphate and acetonitrile in the ratio 35:65 at a flow rate of 1.0 ml/min. A PDA indicator at 288 nm was used to finish the discovery process. Results: Under these perfect conditions, the baseline drug separation may be completed in less than 3.0 minutes with good resolution. The discovery procedure was completed by using a PDA indicator at 288 nm. The improved test settings were validated by adhering to ICH Q2 (R1) guidelines. Conclusion: The methods that were suggested have been found to be effective and explicit, making them suitable for regular examination of the structure of tablets containing ivabradine hydrochloride.


Cite this article:
Swapnali Suresh Zurange, Subodh Anil Gangurde. Analytical Method Development and Validation of Ivabradine Hydrochloride using Advanced Analytical Techniques. Research Journal of Pharmacy and Technology. 2025;18(10):4765-8. doi: 10.52711/0974-360X.2025.00685

Cite(Electronic):
Swapnali Suresh Zurange, Subodh Anil Gangurde. Analytical Method Development and Validation of Ivabradine Hydrochloride using Advanced Analytical Techniques. Research Journal of Pharmacy and Technology. 2025;18(10):4765-8. doi: 10.52711/0974-360X.2025.00685   Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-10-24


REFERENCES:
1.    Sandipan R. Quality by design: A holistic concept of building quality in pharmaceuticals. Int J Pharm Biomed Res. 2012; 3:100-108. 
2.    Bhatt DA, Smita Rane. QbD Approach to Analytical Method development and its validation. Int. J. Pharm. Pharm. Sci. 2011, 3(1), 179-187. 
3.    Mamatha B, Ushasree G, Uma, V. Analytical Techniques For The Estimation Of Meloxicam In Bulk And Pharmaceutical Dosage Forms: A Review. Int. J. Pharm. Res. Ana. 2015. 5; 74-77. 
4.    Snyder LR, Stadalius MA, High-Performance Liquid Chromatography: Advances and Perspectives. C. Horvath, ed. Academic Press. 1983. San Diego, CA, 3; 157-158. 
5.    Patil AS, Pethe AM. Quality by Design (QbD): A new concept for development of quality pharmaceuticals. Int. J Pharm. Qua. Ass. 4; 13-19 
6.    Savie IM, Experimental design to quality by design in pharmaceutical legislation. Accreditation and Quality Assurance. 2012; 17:627-633.
7.    Gilmour SG, Response surface designs for experiments in bioprocessing’ Biometrics, 2006; (62):323-331. 
8.    Bruns RE, Scarminio IS, Neto BB, Statistical design- Chemometrics, Amsterdam, 2006:338-350. 
9.    Willard, M.; Dean, S.; Instrumental method of analysis 7th ed. New Delhi.CBS publication and distributors 1986; p. 684-689. 
10.    Scott P. Principles and Practice of Chromatography, Chrome-ED Book Series; 1-2. p. 12-14. 
11.    Sethi PD. HPLC Quantitaive Analysis of Pharmaceutical Formulations. 1st ed. CBS Publishers and Distributors; 1996. p. 38-43. 
12.    Lindsay S. High Performance Liquid Chromatography. John Wiley and Sons Publication; 1997. p.14. 
13.    James S, James B. Encyclopedia of pharmaceutical technology. New York: Marcel Dekker INC. 1998; 1. p.217-224. 
14.    International Conference on Harmonisation (ICH) Tripartite Guideline, ICH Q2(R1), October, 1994. 16. 
15.    International Conference on Harmonisation (ICH) Tripartite Guideline, ICH Q1A(R2), February, 2003.
16.    International Conference on Harmonisation (ICH) Tripartite Guideline, ICH Q8(R2), August, 2009.
17.    FDA Guidance for Industry, Analytical Procedures and Method Validation, CDER, August 2000.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available