Author(s): Nirmal Thakker, Gajanan Shinde, Abhay Dharamsi, Vishnu Choudhari, Sarita Pawar

Email(s): nirmalthakker117@yahoo.com

DOI: 10.52711/0974-360X.2022.00485   

Address: Nirmal Thakker1,2*, Gajanan Shinde2, Abhay Dharamsi2, Vishnu Choudhari3, Sarita Pawar4
1Application Support, Spinco Biotech Private Limited, Ahmedabad, Gujarat, India.
2Department of Pharmacy, Parul University, Vadodara, Gujarat, India.
3School of Pharmacy, Dr. Vishwanath Karad MIT World Peace University, MIT Campus, Kothrud, Pune, MH, India.
4Department of Pharmaceutical Chemistry, Sanjivani College of Pharmaceutical Education and Research, Kopargaon, MH, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 7,     Year - 2022


ABSTRACT:
A simple, precise bioanalytical UPLC Tandem Mass Spectroscopy gradient elution method was developed and validated for simultaneous estimation of Olmesartan Medoximil (OLM) and Metoprolol Succinate (MET) in human plasma. The quantitation carried out using Shimadzu Shimpack-C18 GIST AQ (50 mm X 2.1 mm, 1.9 µm) column and the mobile phase A comprises of 0.1% formic acid and mobile phase B as acetonitrile used for gradient elution. Analysis completed within run time of 4 min at the mobile phase flow rate of 0.3mL/min. The retention time of metoprolol succinate and olmesartan medoximil were 1.029 min and 2.514min, respectively. Analytes were extracted using acetonitrile as extracting solvent. The method validated in terms of linearity, accuracy, precision, lower limit of quantitation, method sensitivity and various solution stability parameters. Linearity of olmesartan medoximil and metoprolol succinate was in the range of 5-1500ng/mL. All the method validation parameters were determined as per ICH, EMA and FDA guidelines and falls under the stated acceptance criteria. The presented work provides a validated bioanalytical method for simultaneous determination of olmesartan medoximil and metoprolol succinate in human plasma. The method is accurate, simple, precise, fast and suitable for its application for bioequivalence and pharmacokinetic studies.


Cite this article:
Nirmal Thakker, Gajanan Shinde, Abhay Dharamsi, Vishnu Choudhari, Sarita Pawar. Development and Validation of Bioanalytical Method for Simultaneous Estimation of Olmesartan medoximil and Metoprolol succinate by UHPLC-MS/MS in human plasma. Research Journal of Pharmacy and Technology. 2022; 15(7):2909-6. doi: 10.52711/0974-360X.2022.00485

Cite(Electronic):
Nirmal Thakker, Gajanan Shinde, Abhay Dharamsi, Vishnu Choudhari, Sarita Pawar. Development and Validation of Bioanalytical Method for Simultaneous Estimation of Olmesartan medoximil and Metoprolol succinate by UHPLC-MS/MS in human plasma. Research Journal of Pharmacy and Technology. 2022; 15(7):2909-6. doi: 10.52711/0974-360X.2022.00485   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-7-7


REFERENCES:
1.    Sweetman SC. Martindale: The complete drug reference. 35th edn. London, UK: Pharmaceutical Press; 2007. p. 1224.
2.    Dash AK, Palo A. Stress induced method development and validation of olmesartan in bulk and pharmaceutical dosage form by UV Spectrophotometric method; https://www.pharmatutor.org/articles/stress-induced-method-development-and-validation-of-olmesartan [Last accessed on April 01, 2021].
3.    British Pharmacopoeia. Vol. II. London: The British Pharmacopoeial commission 2010. p. 1419.
4.    Indian Pharmacopoeia. Government of India, Ministry of Health and Family Welfare. 6th ed. Vol. II. Ghaziabad: Indian Pharmacopoeia Commission; 2010. p. 1681.
5.    Ritesh N. Pancholi S. Validated stability indicating LC-DAD method for determination of olmesartan medoxomil in tablets exposed to stress conditions. Acta Pharm Sci 2009; 51:323-31.
6.    Prabhakar V. Vipan K. Bharti S. Development and validation of an RP-HPLC method for estimation of olmesartan medoxomil in tablet formulations and stability studies. J Pharm Res 2010; 3: 1015-1018.
7.    Pai N. Sawant S. Development and validation of RP-HPLC method for estimation of olmesartan medoxomil in tablet dosage form. Research J. Pharm. and Tech. 2013; 6(11): 1279-1284.
8.    Patel R. Patel M. Raj H. Shah N. Forced degradation studies of olmesartan medoxomil and characterization of its major degradation products by LC-MS/MS, NMR, IR and TLC. Asian J. Pharm. Ana. 2015; 5(3): 119-125. doi:10.5958/2231-5675.2015.00019.8
9.    Rao T. Vijayalakshmi A. Apparao K. Krishnarao N. A new analytical method validation and quantification of olmesartan medoxomil and its related impurities in bulk drug product by HPLC. Asian J. Pharm. Tech. 2017; 7(3): 147-152. doi:10.5958/2231-5713.2017.00024.1
10.    Babu K. Jayakar B. Vinoth Kumar G. Absorption correction method for estimation of amlodipine besylate and olmesartan medoxomil in combined tablet dosage form. Asian J. Research Chem. 2011; 4(7):1100-1102.
11.    Shah S. Asnani A. Kawade D. Dangre S. Spectrophotometric method for simultaneous estimation of olmesartan medoxomil and amlodipine besylate in pharmaceutical preparations. Research J. Pharm. and Tech. 2012; 5(7): 955-957.
12.    Kachave R. Bhadane R. Wagh R. Jain D. Simultaneous estimation of olmesartan medoxomil and hydrochlorothiazide by spectrophotometry in tablet formulation. Research J. Pharm. and Tech. 2010; 3(4): 1047-1049.
13.    Patel R. Patel M. Raj H. Shah N. Development and validation of stability indicating HPLC method for olmesartan medoxomil and indapamide in tablet. Asian J. Pharm. Res. 2015; 5(1): 15-23. doi:10.5958/2231-5659.2015.00016.8
14.    Saravanan G. Bajidbhee S. Sri Krishnanjaneyulu I. Development and validation of RP-HPLC method for simultaneous estimation of hydrochlorothiazide and olmesartan medoxomil in bulk and pharmaceutical dosage form. Asian J. Research Chem. 2015; 8(2): 147-152. doi:10.5958/0974-4150.2015.00026.7
15.    Priyadharisini J. Saraswathi D. Ajitha A. Jerad S. RP-HPLC determination of olmesartan medoxomil and amlodipine besylate in tablets. Research J. Pharm. and Tech. 2011; 4(6): 903-904.
16.    Raja B. Lakshmana R. Development and validation of a reversed phase HPLC method for simultaneous estimation of olmesartan medoxomil and hydrochlorothiazide in combined tablet dosage form. Int J Res Pharm Chem. 2011; 3: 714-717. doi.org/10.13040/IJPSR.0975-8232.1(12).80-84
17.    Patil P. More H. Pishwikar S. RP-HPLC method for simultaneous estimation of amlodipine besylate and olmesartan medoxomil from tablet. Int J Pharm Pharm Sci. 2011; 3(3):3-6.
18.    Nagavalli D. Venkata S. Aluri B. Development of UV spectrophotometric method for the simultaneous estimation of olmesartan medoxomil and atorvastatin calcium in tablet by simultaneous equation and first order derivative method. Journal of Pharmacy research. 2011; 4(6): 1711-1712.
19.    Wankhede S. Wadkar S. Raka K. Chitlange S. Simultaneous estimation of amlodipine besylate and olmesartan medoxomil in pharmaceutical dosage form. Journal of Pharmaceutical Sciences. 2009; (5): 563-567. doi:10.4103/0250-474X.58190
20.    Verma N. Ghosh A. Chattopadhyay P. UV- Spectrophotometric determination of metoprolol succinate. Research J. Pharm. and Tech. 4(2); 2011: 271-272.
21.    Phale M. Hamrapurkar P. A Validated and Simplified RP-HPLC method for metoprolol succinate from bulk drugs. Asian J. Research Chem. 2009; 2(2): 119-122.
22.    Soni S. Verma R. Verma D. Verma A. Analytical method development and validation of metoprolol succinate by HPLC and ultraviolet spectroscopy technique. Research J. Pharm. and Tech. 2021; 14 (2): 931-937. Doi:10.5958/0974-360X.2021.00166.9
23.    Mahvash I. Shobha Rani R. Estimation of metoprolol in human plasma by HPLC method. Int. J. Pharm. Pharm. Sci. 2014; 7(1): 442-446.
24.    Albers S. Elshoff J. Völker C. Richter A. Läer S. HPLC quantification of metoprolol with solid-phase extraction for the drug monitoring of paediatric patients. Biomed. Chromatogr. 2005; 19: 202-207. doi:10.1002/bmc.436
25.    Chabukswar A. Tambe S. Choudhari V. Sharma S. Mohokar M. Chate S. Ratio derivative spectrophotometry method for simultaneous estimation of metoprolol and amlodipine in their combined dosage form. Research J. Pharm. and Tech. 2012; 5(7): 950-954.
26.    Vora B. Parmar R. Nayak P. Shah D. Development and validation of the simultaneous UV spectrophotometric method for estimation of metoprolol succinate and olmesartan medoxomil in the tablet dosage form. Pharmaceutical Methods. 2012; 3(1): 44–47. doi:10.4103/2229-4708.9772
27.    Chabukswar A. Mohokar M. Choudhari V. Sharma S. Tambe S. Pagare B. Absorption corrected method and isoabsorptive point method for simultaneous estimation of metoprolol and amlodipine in their combined dosage form. International Journal of Pharmaceutical Sciences and Drug Research. 2012; 4(4): 240-244.
28.    Venkatachalam T. Kishor K., Kalai S. Srinivasan R. Mariammal R. Lalitha K. New spectrophotometric method applied to the simultaneous determination of metoprolol succinate and hydrochlorthiazide. Asian J. Research Chem. 2010; 3(2): 464-467. DOI: 10.4103/0250-474X.44606
29.    Rjanit S. Paras V. Raj H. Absorption correction method for simultaneous estimation of nifedipine and metoprolol succinate in their synthetic mixture using spectrophotometry. Asian J. Pharm. Tech. 2015; 5 (1): 13-16.doi:10.5958/2231-5713.2015.00003.3
30.    Garg G. Saraf S. Simultaneous estimation of ramipril and metoprolol tartrate in combined dosage forms. J Indian Chem. Soc. 2007; 84: 609-11.
31.    Baldania S. Parmar A. Bhatt K. Shah D. Chhalotiya U. Simultaneous estimation of metoprolol succinate and olmesartan medoxomil in pharmaceutical formulation by TLC-densitometric method. ISRN Analytical Chemistry. 2012; 2012: 1-7. doi.org/10.5402/2012/245429
32.    Wankhede S. Dixit N. Zambare S. Chitlange S. Development and validation of RP-HPLC Method for quantitative estimation of atorvastatin calcium and metoprolol succinate in combined dose capsule formulation. Asian J. Research Chem. 2010; 3(3): 663-665.
33.    Neelima R. Durga Devi N. Prameela R. Madhavi B. Praveen P. Mrudula B. Determination of metoprolol succinate and atorvastatin calcium in capsules using RP-HPLC. Asian J. Research Chem. 2010; 3(4): 892-894.
34.    Rao P. Rahaman S. Prasad R. Reddy G. RP-HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. Int J Pharm Res Dev. 2010; 9: 69-76.
35.    Thakker NM, Choudhari VP, Kuchekar BS, Panchal HB, Rakholiya DR, Murugan R. Development and validation of a stability indicating RP-HPLC method for simultaneous estimation of olmesartan medoxomil and metoprolol succinate in pharmaceutical dosage form. Pharmaceutical Methods. 2012; 3(2): 84–89. doi:10.4103/2229-4708.103880
36.    Singh A. Dwivedi J. Gandhi S. Development and validation of stability-indicating RP-HPLC method for determination of metoprolol succinate and olmesartan medoxomil in bulk and in formulation. Research J. Pharm. and Tech. 2014; 7(12): 1368-1373.
37.    Mehulkumar P. Ramesh V. Vinay kumar V. Srinivas R. Diwan P. Simultaneous spectroscopic estimation of amlodipine besylate and olmesartan medoximil in tablet dosage form. Asian J Research Chem. 2009; 2(2): 127-130.
38.    International Conference on Harmonization (ICH). Guidance for Industry, Q1A (R2), stability testing of new drug substances and products. Geneva: IFPMA; 2003.
39.    Food and Drug Administration: USFDA Guidance for Industry: Bioanalytical Method Validation 2001. https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf [Last accessed on April 01, 2021].
40.    Van Amsterdam P: The EMA Bioanalytical Method Validation Guideline: process, history, discussions and evaluation of its content 2013. https://e-b-f.eu/wp-content/uploads/2018/05/bcn2012-S62.-5_van_amsterdam.pdf [Last accessed on April 01, 2021].

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 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available