Author(s):
Meenakshi Bhatia, Rameshwar Dass, Goutam Rath
Email(s):
rdladwa01@gmail.com
DOI:
10.52711/0974-360X.2022.00672 
Address:
Meenakshi Bhatia1, Rameshwar Dass1,2*, Goutam Rath3
1Department of Pharmaceutics, Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India.
2Guru Gobind Singh College of Pharmacy, Yamunanagar, Haryana, India.
3Department of Pharmaceutics, Siksha O Anusandhan (Deemed to be University), Bhubaneswar, Odisha, India.
*Corresponding Author
Published In:
Volume - 15,
Issue - 9,
Year - 2022
ABSTRACT:
Itopride hydrochloride (ITH) is currently used for the management of acute prokinetic disorders. In recent research, the determination of ITH in plasma, a new economic, prompt, and isocratic RP-HPLC bioanalytical approach, was established. This method is valid for quantifying the low concentration of drugs in plasma trials which is the demand to be improved. A HILIC column with a separation phase of MeOH: Buffer (30:70 v/v) and a flow with one millilitre per minute, as well as a UV sensor at 258nm, was used to achieve chromatographic high separation. The pharmacokinetic parameters were determined using blood from rabbits after administration of oral suspension containing ITH particles (1mg/kg). The retention time for both ITH and ornidazole, an internal standard (IS), was found to be 6.249min and 4.843 respectively. The statistical interpretation of the results was confirmed. The linearity assortment of the drug was 2-15µg/mL, and the recovered ITH and IS were found to be 100.1% and 99.8% with accuracy, whereas the analysis of the sample was 99.87%, respectively. In addition, the oral pharmacokinetic parameters were successfully analyzed by using this method for ITH and OND. The highest plasma concentration (Cmax) of ITH was 6.805 (mcg/mL) at (Tmax) 1hr and half-life was found at 4.022 hours, correspondingly. The present analytical method has been efficiently used to study the pharmacokinetics of drug combinations.
Cite this article:
Meenakshi Bhatia, Rameshwar Dass, Goutam Rath. RP-HPLC bioanalytical Method of Itopride hydrochloride for determination and its Pharmacokinetic applications. Research Journal of Pharmacy and Technology. 2022; 15(9):4012-6. doi: 10.52711/0974-360X.2022.00672
Cite(Electronic):
Meenakshi Bhatia, Rameshwar Dass, Goutam Rath. RP-HPLC bioanalytical Method of Itopride hydrochloride for determination and its Pharmacokinetic applications. Research Journal of Pharmacy and Technology. 2022; 15(9):4012-6. doi: 10.52711/0974-360X.2022.00672 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-9-32
REFERENCES:
1. Clarrett DM, Hachem C. Gastroesophageal Reflux Disease (GERD). Mo Med. 2018 May-Jun;115(3):214-218. PMID: 30228725; PMCID: PMC6140167.
2. Salunke Poonam A., Kadam Lalit, Jaiswal Nikita, Jain Roshan, Patil Shital, Wagh Rupali, Barhate S. D. Quantification of Itopride Hydrochloride from tablet dosage form by visible Spectroscopy. Research J. Pharm. and Tech. 2018; 11(1): 121-125 doi: 10.5958/0974-360X.2018.00023.9
3. Sweetmann SC. Martindale, The Complete Drug Reference. 38th ed. The Pharmaceutical Press. 2014;1850.
4. Sabnis SS, Dhavale ND, Jadhav VY, Gandhi SV. Spectrophotometric simultaneous determination of rabeprazole sodium and itopride hydrochloride in capsule dosage form. Spectrochim Acta A Mol Biomol Spectrosc. 2008 Mar;69(3):849-52. doi: 10.1016/j.saa.2007.05.048.
5. Satapathy T, Panda PK, Goyal AK, Rath G. Evaluation of anti-GERD activity of gastro retentive drug delivery system of itopride hydrochloride. Artif Cells Blood Substit Immobil Biotechnol. 2010 Aug;38(4):200-7. doi: 10.3109/10731191003776751.
6. Mubeen G, Prakash V, Uvesh K. Two Spectrophotometric Methods for Determination of Ornidazole in Tablets. Orient J Chem 2010;26(1).
7. D’Souza K, Syeda A, Khatal P, Muddukrishna BS, Vasantharaju SG. Stability Indicating Assay Method Development and Validation for Simultaneous Estimation of Ofloxacin and Ornidazole by RP-HPLC in Bulk: An Application to Tablet Formulation and Dissolution Studies. Indian J of Pharmaceutical Education and Research. 2021;55(2):607-13.
8. Marakatham S, Shanmugapandiyan P. Bioanalytical Method Development and Validation of Doravirine, Lamavudine and Tenofovir Disoproxil Fumarate using HPLC in Human Plasma. Research Journal of Pharmacy and Technology. 2021; 14(8):4087-1. doi: 10.52711/0974-360X.2021.00708
9. Khater Ahmed Saeed AL-Japairai, Bappaditya Chatterjee, Syed Mahmood, Samah Hamed Almurisi. A Bioanalytical Method for Quantification of Telmisartan in rat Plasma; Development, Validation and Application to Pharmacokinetic Study. Research Journal of Pharmacy and Technology. 2021; 14(4):2139-4. doi: 10.52711/0974-360X.2021.00379.
10. Dibya Das, Dhiman Halder, Himangshu Sekhar Maji, Pintu Kumar De, Sudipta Saha, Navjot Singh, Tapan Kumar Pal. Introduction of an Innovative approach for Bioanalytical Method Development and Validation of Febuxostat by using LC-ESI-MS/MS in Human Plasma. Research Journal of Pharmacy and Technology. 2021; 14(8):4060-6. doi: 10.52711/0974-360X.2021.00703
11. ICH, Q2A, Text on Validation of Analytical Procedures. International Conference on Harmonization. 1994.
12. ICH. (2005) Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization (ICH), Q2(R1), Geneva, 17
13. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Center for Veterinary Medicine (CVM). 2018
14. Puranik M, Bhawsar DV, Rathi P, Yeole PG. Simultaneous Determination of Ofloxacin and Ornidazole in Solid Dosage Form by RP-HPLC and HPTLC Techniques. Indian J Pharm Sci. 2010 Jul;72(4):513-7. doi: 10.4103/0250-474X.73937.
15. Shaik Harun Rasheed, M. Arief, P. Sandhya Vani, Silpa Rani Gajavalli, G. Venkateswarlu, K. Shahul Hussain, N. Vinay Kumar, Y. Krishna Reddy. Simultaneous Estimation of Rabeprazole Sodium and Itopride Hydrochloride in Capsule Dosage Form by UV Spectrophotometry. Research J. Pharm. and Tech. 4(4): April 2011; Page 558-560.
16. Mukta D. Naykode, Durgacharan A. Bhagwat, Swapnil D. Jadhav, Harinath N. More. Analytical and Bioanalytical Method for Quantification of Pure Azilsartan, Not its Salts by RP-HPLC. Research J. Pharm. and Tech. 2017; 10(3): 708-714. doi: 10.5958/0974-360X.2017.00133.0
17. Karunakaran K, Navaneethan G, Elango K, Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Determination of Paracetamol, Tramadol HCl and Domperidone in a Combined Dosage Form. Tropical Journal of Pharmaceutical Research. 2012;11:99-106.
18. Kamal Hossain, Kamrun Nahar, Mohammed Ehsanul Hoque Mazumder. Development and Validation of a Bioanalytical method for the Determination of Levamisole Residue in Backyard Poultry Egg. Research J. Pharm. and Tech. 2017; 10(7): 2249-2254. doi: 10.5958/0974-360X.2017.00398.5
19. B Dhandapani, N Anjaneyulu, K Vinod Kumar, Shaik Harun Rasheed, M Ramakotaiah. HPTLC Method Development and Validation for the Estimation of Rabeprazole Sodium and Itopride Hydrochloride in Tablet Dosage form. Research J. Pharm. and Tech. 3(2): April- June 2010; Page 475-477.
20. M. Seetha Devi, G. Raveendra Babu, NVL Sirisha Mulukuri. A new stability indicating RP-HPLC method for the simultaneous estimation of Diloxanide and Ornidazole in bulk and Pharmaceutical Dosage forms. Research J. Pharm. and Tech 2017; 10(12): 4247-4254. doi: 10.5958/0974-360X.2017.00778.8
21. Palaksha MN, Tamizh Mani T, Manjunatha E, G P Senthil Kumar. Comparative study of In-Vivo effects of Glipizide and Metformin HCl on plasma concentration of Aminophylline in healthy rabbits. Asian J. Pharm. Res. 2020; 10(2):62-66. doi: 10.5958/2231-5691.2020.00012.X