Author(s):
Darshini H B, Mounika, Rama Bukka, Abdul Naim
Email(s):
rama.bukka@nargund.edu.in
DOI:
10.52711/2231-5675.2026.00005 
Address:
Darshini H B, Mounika, Rama Bukka*, Abdul Naim
Department of Pharmaceutics, Nargund College of Pharmacy, Bengaluru - 85, Karnataka, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 1,
Year - 2026
ABSTRACT:
Objective: To develop and validate a simple, accurate, precise, and reproducible high-performance liquid chromatographic (HPLC) method for the estimation of the antiemetic drug Ondansetron hydrochloride in pharmaceutical formulations. Methods: The chromatographic separation was carried out using a C18 column (4.6 × 250mm, 5 µm) maintained at room temperature. The mobile phase consisted of 0.1% ortho phosphoric acid and acetonitrile in a 75:25 v/v ratio, delivered in a low-pressure gradient mode at a flow rate of 1mL/min. Detection was performed using a Photo Diode Array (PDA) detector at 310nm, and the injection volume was 20 µL. The developed method was validated as per ICH guidelines for parameters such as linearity, specificity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. Results: Ondansetron hydrochloride showed a well-resolved peak with a retention time of 5.4 minutes. The method exhibited excellent linearity within the concentration range of 4–28µg/mL, with high correlation coefficient values. Validation studies confirmed the method’s accuracy, precision, and robustness. The recovery values were close to 100%, and the relative standard deviation (RSD) was found to be low, indicating high reproducibility. Conclusion: The developed HPLC method is accurate, precise, specific, and robust, making it suitable for the routine quantitative estimation of Ondansetron hydrochloride in pharmaceutical formulations.
Cite this article:
Darshini H B, Mounika, Rama Bukka, Abdul Naim. A High-Precision RP–HPLC Method for Ondansetron Hydrochloride: Development, Optimization and Validation. Asian Journal of Pharmaceutical Analysis. 2026; 16(1):29-3. doi: 10.52711/2231-5675.2026.00005
Cite(Electronic):
Darshini H B, Mounika, Rama Bukka, Abdul Naim. A High-Precision RP–HPLC Method for Ondansetron Hydrochloride: Development, Optimization and Validation. Asian Journal of Pharmaceutical Analysis. 2026; 16(1):29-3. doi: 10.52711/2231-5675.2026.00005 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-1-5
REFERENCE:
1. Dedania Z, Dedania R, Karkhanis V, Sagar GV, Baldania M, Sheth N. RP-HPLC Method for Simultaneous Estimation of Omeprazole and Ondansetron in Combined Dosage Forms. Asian J Research Chem. 2009; 2(2): 108–11.
2. Shirole P, Sanap DP, Jadhav K. Stability indicating rp-hplc method development for ondansetron hydrochloride estimation in bulk. Actapharm. 2025; 63(1): 134.
3. Tomczak S, Radwan V, Jelińska A, Stawny M. Application of the HPLC Method in Parenteral Nutrition Assessment: Stability Studies of Ondansetron. Processes. 2021 Mar 3; 9(3): 453.
4. Snigdha Bhardwaj, Sonam Bhatia, Shaminder Singh. Transdermal Delivery of Ondansetron Hydrochloride in the management of Hyperemesis Gravidarum. IJPSR. 2020 Aug 31; 11(8): 206–14.
5. Chen F chao, Wang L hai, Guo J, Shi X ya, Fang B xia. Simultaneous Determination of Dexamethasone, Ondansetron, Granisetron, Tropisetron, and Azasetron in Infusion Samples by HPLC with DAD Detection. Journal of Analytical Methods in Chemistry. 2017; 2017: 1–7.
6. Krishnaiah YSR, Raju V, Shiva Kumar M, Rama B, Raghumurthy V, Ramana Murthy KV. Studies on Optimizing In Vitro Transdermal Permeation of Ondansetron Hydrochloride Using Nerodilol, Carvone, and Limonene as Penetration Enhancers. Pharmaceutical Development and Technology. 2008 Jan; 13(3): 177–85.
7. Bukka R, Hn C. High-performance liquid chromatographic estimation method for transdermal diffusion study of granisetron. Asian J Pharm Clin Res. 2021 Apr 7; 105–8.
8. Mushabbar Basha, B. Praveena, M. Srinidhi, SK.A. Rahaman. Method development and validation of ondansetron in bulk and pharmaceutical dosage form by stability-indicating RP-HPLC method. International Journal of PharmTech Research. 2013; 5(1): 86–98.
9. Alam Imran, Jat R.K, Singh Rambir, Srivastava Varnika, Srivastava Sunny. Development and validation of reversed-phase hplc method for estimation of ondansetron hydrochloride in bulk drug. International Research Journal of Pharmacy. 2012; 3(2).
10. Fang B Xia, Wang L Hai, Chen F Chao, Li P, Shi X Ya. A simple HPLC method for the determination of butorphanol tartrate and ondansetron hydrochloride in patient-controlled analgesia solution. Acta Chromatographica. 2018 Mar; 30(1): 43–6.
11. Deshmukh TB, Deo SS, Inam F, Lambat TL, Gurubaxani SB, Choudhari AV. Development and validation of ondansetron hydrochloride in pharmaceutical dosage form by rp- hplc method. International Journal of Advances in Science Engineering and Technology. 2015.
12. Sheshala R, Darwis Y, Khan N. Development and Validation of an RP–LC–UV Method for the Determination of Ondansetron: Application to Pharmaceutical Dosage Forms. Chroma. 2009 Jul; 70(1–2): 75–81.
13. Sravanthi G, Gandla K, Repudi L. New analytical method development and validation for estimation of molnupiravir in bulk and tablet dosage form by RP-HPLC method. Cell Mol Biomed Rep. 2023 Sep 1; 3(3): 130–6.
14. Alquadeib BT. Development and validation of a new HPLC analytical method for the determination of diclofenac in tablets. Saudi Pharmaceutical Journal. 2019 Jan; 27(1): 66–70.
15. Bauer S, Störmer E, Kaiser R, Tremblay P, Brockmöller J, Roots I. Simultaneous determination of ondansetron and tropisetron in human plasma using HPLC with UV detection. Biomedical Chromatography. 2002 May; 16(3): 187–90.
16. Tabassum K, Sarvesh R. Analytical method development and validation studies of ticagrelor tablets by RP-HPLC. Int J App Pharm. 2017 Jul 13; 9(4): 10.
17. Dutta Tejaswi DrJK. Estimation of ondansetron hydrochloride by RP-HPLC. EPRA. 2020 May 9; 5(5): 29–34.
18. Shende P, Atrey E, Rs G. RP-HPLC Method Development and Validation for Simultaneous Estimation of Ondansetron Hydrochloride and Complexed Famotidine in Bulk and Dosage Form. JAPLR [Internet]. 2017 Jun 26 [cited 2025 Nov 24]; 5(2). Available from: https://medcraveonline.com/JAPLR/rp-hplc-method-development-and-validation-for-simultaneous-estimation-of-ondansetron-hydrochloride-and-complexed-famotidine-in-bulk-and-dosage-form.html
19. A. Lakshmana Rao, G. Akanksha, G. Neelima, G. Sneha, G.V. Pavan Kumar, G. Lavanya. Stability Indicating RP-HPLC Method Development and Validation for the Estimation of Ondansetron in Bulk and their Pharmaceutical Dosage Form. IJRAPS. 2022 Feb 13; 557–63.