Journal of Pharmacy And Bioallied Sciences

ORIGINAL ARTICLE
Year
: 2021  |  Volume : 13  |  Issue : 4  |  Page : 360--366

Analytical quality by design based systematic development and optimization of a sensitive bioanalytical method for estimation cinacalcet HCl in rabbit serum


Sudhanshu Bhusan Routray1, Chinam Niranjan Patra1, Suryakanta Swain2, Bikash Ranjan Jena3 
1 Department of Pharmaceutics, Roland Institute of Pharmaceutical Sciences, Affiliated to Biju Patnaik University of Technology, Rourkela, Odisha, India
2 Department of Pharmacy, School of Health Sciences, The Assam Kaziranga University, Koraikhowa, Jorhat, Assam, India
3 Department of Pharmacy, School of Pharmacy and Life Sciences, Centurion University of Technology and Management, Bhubaneswar, Odisha, India

Correspondence Address:
Dr. Chinam Niranjan Patra
Department of Pharmaceutics, Roland Institute of Pharmaceutical Sciences, Affiliated to Biju Patnaik University of Technology, Rourkela - 760 010, Odisha
India

Context: There is no straightforward method for estimating cinacalcet HCl in biological materials such as serum exists. As a result, the goal of this research is to develop a simple quality by design (QbD) enabled reverse phase-Ultra-Fast Liquid Chromatography (RP-UFLC) model for analyzing cinacalcet HCl in serum. Aim: The current study envisages the development and validation of an isocratic simple, precise, and rapid QbD enabled RP-UFLC method for the quantification of cinacalcet HCl in both solution form and blood samples. Subjects and Methods: The optimum conditions were outlined, selecting three influential factors (CMPs) i.e., mobile phase composition, flow rate, and injection volume. Systematic optimization was performed by 32-Box Benkhen experimental design using response surface methodology. The selected variables are further assessed for observed responses Critical Analytical attributes, i.e., peak area, retention time (Rt), USP Plate count. The optimized method used a chromatographic C18 (100 mm × 4.6 mm i.d) column with mobile phase (acetonitrile and Tetrabutyl Ammonium Hydrogen Sulphate [TBSH]) in the ratio of 1:1, with a flow rate of 1 mL/min with UV at λmax 223 nm. The developed method was found to be specific for cinacalcet HCl, enduring no interference of peaks with an overall analytical Rt of 4.3 min. Results: The Accuracy reported as % recovery was found to be 96.83%–101.32% and 95.18%–102.49% respectively. Inter-day precision (reproducibility) and intra-day precision (repeatability) were found to be 0.22–1.19 standard deviation (SD) and 0.14–2.12 SD respectively. The calibration curve was found to be linear with a regression equation Y = 195.8x + 21852, with R2 0.999 over a concentration range from 100 to 100,000 ng/mL. Conclusion: The required detection and quantitation limits (Limit of Detection and Limit of Quantitation) values were obtained within the acceptance limit based on S/N ratio which indicates the method was sensitive and rapidity of the method. Further, the developed QbD enabled UFLC method was approved and effectively entreated the blood tests to study the pharmacokinetic parameters which indicate a robust, accurate cost-effective method intended for quality control tool for routine systematic analysis in research labs.


How to cite this article:
Routray SB, Patra CN, Swain S, Jena BR. Analytical quality by design based systematic development and optimization of a sensitive bioanalytical method for estimation cinacalcet HCl in rabbit serum.J Pharm Bioall Sci 2021;13:360-366


How to cite this URL:
Routray SB, Patra CN, Swain S, Jena BR. Analytical quality by design based systematic development and optimization of a sensitive bioanalytical method for estimation cinacalcet HCl in rabbit serum. J Pharm Bioall Sci [serial online] 2021 [cited 2022 May 25 ];13:360-366
Available from: https://www.jpbsonline.org/article.asp?issn=0975-7406;year=2021;volume=13;issue=4;spage=360;epage=366;aulast=Routray;type=0