Author(s):
Barla Karuna Devi, Swathi Naraparaju, Sowjanya Chaganti, Nikitha
Email(s):
karuna.barla@gmail.com
DOI:
10.52711/2231-5675.2024.00040 
Address:
Barla Karuna Devi1*, Swathi Naraparaju1, Sowjanya Chaganti1, Nikitha2
1Department of Pharmaceutical Chemistry, Gokaraju Rangaraju College of Pharmacy, Hyderabad - 500090, Telangana, India.
2Department of Pharmaceutical Analysis, Malla Reddy Institute of Pharmaceutical Science, Kompally - 500014, Telangana, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 4,
Year - 2024
ABSTRACT:
The study's primary goal was to create and validate an RP-HPLC method for determining the pharmaceutical dose form and bulk levels of esomeprazole (ESO) and itopride (ITO). The linearity data was obtained in the concentration range of 12µg/mL to 28µg/mL for esomeprazole and 45µg/mL to 105µg/mL foritopride. Trails were conducted to optimize various parameters such as wave length, column, mobile phase ratio etc. The optimized parameters were ODS C18 Inertsil 250 x 4.6mm, buffer: methanol: acetonitrile (ACN)(30:40:30) v/v/v. Optimal detector response for the drugs was achieved at a detection wavelength of 215nm, and the developed methods were verified for specificity, accuracy, precision, sensitivity, robustness, and ruggedness. All parameters met the specification limits as outlined in the ICH guidelines. From linearity response of Esomeprazole and Itopride R2 was calculated as 0.9974 and 0.9981. Esomeprazole and Itopride had retention times (RT) of 4.4min and 2.5min respectively. The developed method can be employed for quality control checks for the pharmaceutical dosage forms.
Cite this article:
Barla Karuna Devi, Swathi Naraparaju, Sowjanya Chaganti, Nikitha. Simultaneous Method Development and Validation of Esomeprazole and Itopride in Bulk and Dosage Forms by RP-HPLC Method. Asian Journal of Pharmaceutical Analysis. 2024; 14(4):222-8. doi: 10.52711/2231-5675.2024.00040
Cite(Electronic):
Barla Karuna Devi, Swathi Naraparaju, Sowjanya Chaganti, Nikitha. Simultaneous Method Development and Validation of Esomeprazole and Itopride in Bulk and Dosage Forms by RP-HPLC Method. Asian Journal of Pharmaceutical Analysis. 2024; 14(4):222-8. doi: 10.52711/2231-5675.2024.00040 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-14-4-4
REFERENCES:
1. Kumar SD, Harish KD. Importance Of Rp-HplcIn Analytical Method Development: A Review. International Journal of Pharmaceutical Sciences and Research. 2012; 3(12): 4627–33. http://dx.doi.org/10.13040/IJPSR.0975-8232.3(12).4626-33.
2. Jadhao AS, Ambhore DP. Biyani KR. Importance of RP-HPLC in Analytical Method Development: A Review. International Journal of Advanced Research in Science, Communication and Technology. 2022; 2(8): 345-351.http://dx.doi.org/10.48175/IJARSCT-4507
3. Nitin M, Mohan UR, Hasan SM, Sayeed Ul. Pharmacodynamic influence of vitamin C and Esomeprazole on gastro protection in pylorus ligation and aspirin induced ulcers in rats. Research J Pharmacology and Pharmacodynamics. 2012; 4(3) 176-180.https://rjppd.org/AbstractView.aspx?PID=2012-4-3-20.
4. AbdelazimAH, RamzyS, ShahinM. Application of Different UV Spectrophotometric Methods for QuantitativeAnalysis of Acotiamide and Esomeprazole. Journal of AOAC International. 2022; 105(5):1475-1478. https://doi.org/10.1093/jaoacint/qsac041.
5. Jabeer SK, Srinivasa P, Sambasiva UR, Janbee SK, Rao JUM. HPLC and UV Spectrophotometric estimation of Itopride in Pharmaceutical Formulations. Caribbean Journal of Science and Technology. 2016; 4(1): 896.https://caribjscitech.com/index.php/cjst/article/view/54.
6. K.R. Gupta, R. Joshi, R.B. Chawla, S.G. Wadodkar. UV Spectrophotometric Method for the Estimation ofItopride Hydrochloride in Pharmaceutical Formulation. E Journal of Chemistry. 2010; 7(S1): S49-S54. https://doi.org/10.1155/2010/526891.
7. M.C. Sharma, S. Sharma. Spectrophotometric Methods for the Estimation of Esomeprazole magnesium trihydrate in Pharmaceutical Formulations Using Indigo Carmine Reagent International Journal of PharmTech Research. 2011; 3(2): 1186-1190.
8. Shebina R, Sanal D, Remya K, Jemi J, Smitha R. Determination of Esomeprazole by Complexation Method. Der Pharma Chemica, 2017; 9(22):101-105.
9. Manal M, Fouad NSR, Asmaa IH. Green UV Spectrophotometric Methods for Simultaneous Determination of Aspirin and Esomeprazole in Laboratory Prepared Capsules. Azhar International Journal of Pharmaceutical and Medical Sciences. 2024; 4 (1): 20-31.
10. Mohan RP, Veereswara RR, Mukherjee PB, Sarvanan VS, Gopal N, Tukaram M, Shivakumar K. UV Spectrophotometric Determination of Esomeprazole in Tablet Dosage Forms. Asian Journal of Chemistry. 2007; 19(4): 3250-3252.
11. Raja JK, Pavithro JK, Sowjanya P, Bhavani D, Dharani M, Satyanarayana T. Method development and validation of itopride using UV spectroscopic method in bulk drug and marketed Formulation. World Journal of Pharmacy and Pharmaceutical Sciences. 2015; 10(8): 1644-1651.
12. ShechinahFC, Srinivasulu K, Kumar VP, Saradhi SV. Visible spectrophotometric determination of Itopride hydrochloride in pharmaceutical Formulations. International Journal of Chemical Sciences. 2008; 6(2): 832-83813.
13. Choudhary B, Goyal A, Khokra SL. New Visible Spectrophotometric Method for Estimation ofItopride Hydrochloride from Tablets Formulations Using Methyl Orange Reagent. International Journal of Pharmacy and Pharmaceutical Sciences. 2009; 1(1) 159-162.
14. Patil S, Dhabale PN, Kuchekar S. Development and Statistical Validation of Spectrophotometric Method for Estimation of Esomeprazole in Tablet Dosage Form. Asian Journal of Research in Chemistry. 2009; 2(2):154-156.
15. Rasheed SH, Arief M, Sandhya P, Gajavalli RS, Venkateswarlu G, Shahul K, N. Vinay, Y. Krishna. Simultaneous Estimation of Rabeprazole Sodium and Itopride Hydrochloride in Capsule Dosage Form by UV SpectrophotometryResearch J Pharm and Tech. 2011; 4(4): 558-560. https://rjptonline.org/AbstractView.aspx?PID=2011-4-4-8
16. M.S. Jain, Y.S. Agarwal, R.B Chavhan, M.M. Manoj, S.D. Barhate. UV Spectrophotometric Methods for Simultaneous Estimation of Levosulpiride and Esomeprazole in Capsule Dosage Form. Asian Journal of PharmaceuticalAnalysis. 2012; 2(4) 106-109.
17. Belal F, Sharaf M, Tolba MM, Alaa H. Enhanced spectrofluorimetric determination of esomeprazole and pantoprazole in dosage forms and spiked human plasma using organized media. Luminescence. 2015; 30(3): 343-51. https://doi.org/10.1002/bio.2737.
18. Walash MI, Ibrahim F, Eid MI, El Abass SA. Stability-indicating spectrofluorimetric method for determination of itopride hydrochloride in raw material and pharmaceutical formulations. Journal of Fluorescence. 2013; 23(6): 1293-300. https://doi.org/10.1007/s10895-013-1263-1.
19. Patel RK, Raval BP, Patel BH, Patel LJ. Reverse Phase High Performance Liquid Chromatographic method forthe simultaneous estimation of Esomeprazole and Itopride in Capsule. Der Pharma Chemica. 2010; 2(1): 251-26020.
20. Gohil D, Bhamre P, Jain R, Rajput S. Simultaneous Estimation of Esomeprazole Magnesium Trihydrate, Itopride Hydrochloride and Mosapride Citrate by RP-HPLC Method: Optimization, Development, Validation and Application to Laboratory Sample. International Journal of Pharmaceutical Science and Research. 2014; 5(3): 907-912. http://dx.doi.org/10.13040/IJPSR.0975-8232.5(3).907-1.
21. Umamaheswari D, Kumar M, Jayakar B, Chatakonda R. Method development and validation of Itopride Hydrochloride and Rabeprazole Sodium in pharmaceutical dosage form by Reversed Phase High Performance Liquid Chromatography. Journal of Chemical and Pharmaceutical Research. 2010; 2(5):399-417.
22. Hiral J, Varachhiya R, Rohan KB, Suresh J. Development and Validation of Spectroscopic Simultaneous Equation Method for Simultaneous Estimation of Itopride Hydrochloride and Omeprazole in Synthetic Mixture. Asian Journal of Pharmaceutical Research. 2019; 9(4): 238-242. http://dx.doi.org/10.5958/2231-5691.2019.00038.8.
23. Anirbandeep B, Uttam B, Animesh G, Bappaditya C, Uday SC, Amlan KS, Tapan K. LC–MS Simultaneous Determination of Itopride Hydrochloride and Domperidone in Human Plasma. Chromatographia. 2009; 69: 1233–1241. http://dx.doi.org/10.1365/s10337-009-1032-0.
24. HeonWL, Ji HS, Seung KC, Kyung TL. Determination of itopride in human plasma by liquid chromatography coupled to tandem mass spectrometric detection: Application to a bioequivalence. Analytica Chimica Acta. 2007; 583(1): 118-123. http://dx.doi.org/1016/j.aca.2006.09.06.
25. P. Joshi, S. Bhoir, A.M. Bhagwat, K. Vishwanath, R.K. Jadhav. Identification of Forced Degradation Products of Itopride by LC-PDA and LC-MS. Indian Journal of Pharmaceutical Sciences. 2011; 73(3): 287-291. http://dx.doi.org/10.4103/0250-474X.93516
26. Santosh RK, Mulik RS, Bachhav. Bulk Solution Assay Test Procedure Development and validation for Esomeprazole Sodium Injection 40mg as a CPP. Research Journal of Science and Technology. 2021; 13(3): 177-192.https://doi.org/10.52711/2349-2988.2021.00028.
27. B. Dhandapani, N. Anjaneyulu, K. Vinod, S.H. Rasheed, M. Ramakotaiah.HPTLC Method Development and Validation for the Estimation of Rabeprazole Sodium and Itopride Hydrochloride in Tablet Dosage. Research J Pharm and Tech. 2010; 3(2): 475-477.
28. Sathiyaraj M, Vijay AR, Senthil NK. Bioanalytical Method Development and Validation of Esomeprazole in Human Plasma by LCMS/MS. Asian J Research Chem. 2010; 3(2): 477-484.
29. Rao MN, Krishna KBM, Hari B. Development and Validation of a Stability Indicating HPLC Methodfor the Simultaneous Analysis of Esomeprazole and Itopride in Bulk and In Capsules. Journal of Applied Pharmaceutical Science. 2016; 6(2): 72-80. https://doi.org/10.7324/JAPS.2016.60210
30. Sowjanya V. Method Development and Validation for Simultaneous Estimation of Esomeprazole and itopride Hydrochloride in Combined Pharmaceutical Dosage Form and bulk by RP- HPLC Asian Journal of Pharmaceutical Analysis. 2020; 10(2): 91-98. https://doi.org/10.5958/2231-5675.2020.00016.2