Author(s): Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Tapan Kumar Pal

Email(s): dibyadas1990gmail.com

DOI: 10.52711/0974-360X.2021.00618   

Address: Dibya Das1*, Dhiman Halder2, Himangshu Sekhar Maji1, Pintu Kumar De1, Tapan Kumar Pal2
1Department of Pharmaceutical Technology, JIS University, Kolkata.
2Department of Pharmaceutical Technology, Bioequivalence Study Centre, Jadavpur University, Kolkata.
*Corresponding Author

Published In:   Volume - 14,      Issue - 7,     Year - 2021


ABSTRACT:
The aim of this study is to develop and validate an accurate, sensitive, rapid, precise, and simple bioanalytical method for the estimation of Azelnidipine (calcium channel blocker, used in hypertension) in the human plasma by using LC-ESI-MS/MS. The method was developed by gradient conditions using 0.1% Formic Acid in Acetonitrile and Milli-Q water with 10mM Ammonium acetate as a mobile phase with a flow rate of 0.5 mL/min. The Analyte and IS (Metoprolol) were separated by using a C18 Phenomenex Kinetex (50x3mm, 5µ) column. 7.0 minutes was the chromatographic run time. The analyte and IS extracted from plasma by simple protein precipitation technique (PPT). The LOD and LLOQ were found to be 0.53125ng/mL and 1.0625ng/mL, respectively. The extraction recovery of the drug from plasma was high. The other validation parameters were found within the range, as mentioned by USFDA and EMA guidelines.


Cite this article:
Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Tapan Kumar Pal. Special Emphasis on Bioanalytical Method Development and Validation of an Anti-Hypertensive Drug Azelnidipine by LC-ESI-MS/MS in Healthy Human Volunteer’s Blood Plasma. Research Journal of Pharmacy and Technology. 2021; 14(7):3571-7. doi: 10.52711/0974-360X.2021.00618

Cite(Electronic):
Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Tapan Kumar Pal. Special Emphasis on Bioanalytical Method Development and Validation of an Anti-Hypertensive Drug Azelnidipine by LC-ESI-MS/MS in Healthy Human Volunteer’s Blood Plasma. Research Journal of Pharmacy and Technology. 2021; 14(7):3571-7. doi: 10.52711/0974-360X.2021.00618   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-7-15


REFERENCES:
1.    Oizumi K, Nishino H, Koike H, Sada T, Miyamoto M, Kimura T. Antihypertensive effects of CS-905, a novel dihydropyridine Ca++ channel blocker. The Japanese Journal of Pharmacology. 1989; 51(1): 57-64.
2.    Nakamoto M, Ohya Y, Sakima A, Yamazato M, Takishita S. Azelnidipine attenuates cardiovascular and sympathetic responses to air-jet stress in genetically hypertensive rats. Hypertension Research. 2007; 30(4): 359-66.
3.    Jinno T, Iwai M, Li Z, Li J-M, Liu H-W, Cui T-X, et al. Calcium channel blocker azelnidipine enhances vascular protective effects of AT1 receptor blocker olmesartan. Hypertension. 2004; 43(2): 263-9.
4.    Raskapur KD, Patel MM, Captain AD. UV-Spectrophotometric method development and validation for determination of Azelnidipine in pharmaceutical dosage form. Toxicology. 2010; 106: 135-43.
5.    Muralidharan S, Parasuraman S, Venugopal V. Simple validation of Azelnidipine by RP-HPLC Method. Rapports De Pharmacie. 2015; 1: 43 - 5
6.    Pan Y, Zhang J, Ding J, Wang T. Determination of Azelnidipine tablets by HPLC. Qilu Pharmaceutical Affairs. 2008;7: 398-9.
7.    Kawabata K, Urasaki Y. Simultaneous determination of azelnidipine and two metabolites in human plasma using liquid chromatography-tandem mass spectrometry. Journal of Chromatography B. 2006; 844(1): 45-52.
8.    Kawabata K, Samata N, Urasaki Y, Fukazawa I, Uchida N, Uchida E, et al. Enantioselective determination of azelnidipine in human plasma using liquid chromatography–tandem mass spectrometry. Journal of Chromatography B. 2007; 852(1-2): 389-97.
9.    Jian-Jun Z, Hong-Jian J, Xiao-Hua Z, Yu-Bin Z, Hong-Wei F, Da-Wei X, et al. Determination of azelnidipine by LC–ESI-MS and its application to a pharmacokinetic study in healthy Chinese volunteers. Die Pharmazie-An International Journal of Pharmaceutical Sciences. 2008; 63(8): 568-70.
10.    Ding L, Chen Y, Yang L, Wen A. Determination of palonosetron in human plasma by liquid chromatography–electrospray ionization-mass spectrometry. Journal of pharmaceutical and biomedical analysis. 2007; 44(2): 575-80.
11.    Jia J, Nan F, Liang M, Yu Q, Qin Y, Xiang J. Determination and pharmacokinetics of azelnidipine in human plasma by HPLC-MS-MS. Chin J Hospital Pharmacy. 2010; 24.
12.    FDA US. Bioanalytical method validation guidance for industry. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research and Center for Veterinary Medicine. 2018 May.
13.    European Medicines Agency. Guideline on bioanalytical method validation. 21 July. 2011 Jul 21.
14.    Halder D, Dan S, Sarkar P, Das D, Chandra Halder U, Kumar Pal T. LC-MS/MS determination of 4-hydroxynimesulide, an active metabolite of nimesulide and application to bioequivalence study in Indian subjects. European Journal of Mass Spectrometry. 2019;25(5): 399-411.
15.    D. Narmada, P.V. Murali Krishna, Shaik Mohammad Yusuf, B. Ranganayakulu, K. Uday Praveen, P. Raja Abhilash. RP-HPLC method development and validation for estimation of Glibenclamide in tablet dosage form. Asian J. Pharm. Ana. 4(3): July-Sept 2014; Page 125-128.
16.    Govinda Rao Kamala, Sowjanya Vadrevu, Malipeddi Haripriya. Method Development and Validation for Simultaneous Estimation of Omeprazole and Domperidone by RP-HPLC. Asian J. Pharm. Ana. 5(4): 2015; 195-205. doi: 10.5958/2231-5675.2015.00031.9.
17.    Gawai M. N., Surwade K. S., Phadatare D. G. UV Spectrophotometric Method for the estimation of Azilsartan Medoxomil in Bulk Form. Asian J. Research Chem. 2018; 11(5): 791-793 doi: 10.5958/0974-4150.2018.00139.6
18.    Akhilesh Gupta, Swati Rawat, Arun Pandey. Method Development and Photolytic Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 1(2): April-June 2011; Page 29-33.
19.    Swapna J, Madhu C, Srivani M, et al. Analytical method development and method validation for the simultaneous estimation of metformin hydrochloride and pioglitazone hydrochloride in tablet dosage form by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2012;2(3): 85-9.
20.    Renu Solanki, Badri Prakash Nagori, Mahendra Kumar Naval, Joytosh Banerjee. Development and Validation of Simultaneous Estimation Method for Amoxycillin Trihydrate and Tinidazole in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 3(2): April- June 2013; Page 66-71.
21.    Kailash Nath Kaushik, Saurabh Kumar Banerjee. UV Spectrophotometric Method Development for the Determination of Domperidone in Tablet Formulation. Asian J. Research Chem. 2(4): Oct.-Dec. 2009 page 432-433.
22.    S. S. Patil, S. D. Barhate, A. S. Patil, A. V. Patil, H. K. Patil, P. A. Salunke, R. S. Wagh. Novel Mixed Hydrotropic Solubalisation technique for Analytical method development and validation of Acyclovir in bulk and tablet formulation by Spectrophotometry. Asian J. Pharm. Ana. 2019; 9(1): 25-29. doi: 10.5958/2231-5675.2019.00007.3
23.    Sumithra, M., Yuvanesh, P. and Mistry, A., 2016. Analytical method development and validation of ambroxol hydrochloride by UV spectroscopy and forced degradation study and detection of stability. Research Journal of Pharmacy and Technology, 9(7), pp.794-800.
24.    B. Mohammed Ishaq, V.S. Thiruvengada Rajan, S. Angala Parameswari, N. Amruth, M. Madhu, C. Madhusudana Chetty. Analytical Method Development and Validation of Erlotinib by High Performance Liquid Chromatography. Research J. Pharm. and Tech. 4(11): Nov. 2011; Page 1787-1790.

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