Author(s): M. Venkataramana, Maimona Aiman, Ganesh Akula, Yerrolla Soundarya, Salla Pujitha

Email(s): m_ramana100@yahoo.com

DOI: 10.52711/2231-5713.2026.00046   

Address: M. Venkataramana1*, Maimona Aiman2, Ganesh Akula3, Yerrolla Soundarya4, Salla Pujitha5
1,2,3,4Department of Pharmaceutical Analysis, Surabhi Dayakar Rao College of Pharmacy, Rimmanaguda (V), Gajwel (M), Siddipet (D), Telangana – 502312, India.
5Department of Pharmacology, Surabhi Dayakar Rao College of Pharmacy, Rimmanaguda (V), Gajwel (M), Siddipet (D), Telangana – 502312, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 4,     Year - 2026


ABSTRACT:
ABSTRACT: A precise, rapid, and reproducible Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Cetirizine and Montelukast in both bulk drug substances and pharmaceutical formulations. The chromatographic separation was carried out using a Phenomenex Luna C18column (4.6 × 150mm, 5µm) maintained at a temperature of 35°C. The optimized mobile phase consisted of Methanol and Water in the ratio of 70:30 v/v, delivered at a flow rate of 1.0 mL/min.Detection was performed at a wavelength of 230 nm, with a 10µL injection volume and a total run time of 10minutes. Both drugs were effectively separated with sharp, symmetrical peaks and satisfactory retention times. The method was validated according to ICH guidelines, demonstrating acceptable results for linearity, accuracy, precision, robustness, specificity, and system suitability.


Cite this article:
M. Venkataramana, Maimona Aiman, Ganesh Akula, Yerrolla Soundarya, Salla Pujitha. Validated RP-HPLC Method for Determination of Cetirizine and Montelukast in Bulk and Pharmaceutical Formulation. Asian Journal of Pharmacy and Technology. 2026; 16(4):333-8. doi: 10.52711/2231-5713.2026.00046

Cite(Electronic):
M. Venkataramana, Maimona Aiman, Ganesh Akula, Yerrolla Soundarya, Salla Pujitha. Validated RP-HPLC Method for Determination of Cetirizine and Montelukast in Bulk and Pharmaceutical Formulation. Asian Journal of Pharmacy and Technology. 2026; 16(4):333-8. doi: 10.52711/2231-5713.2026.00046   Available on: https://www.ajptonline.com/AbstractView.aspx?PID=2026-16-4-1


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2.    Akhilesh Gupta, Jaydeep Singh Yadav, Swati Rawat, Mayuri Gandhi. Method Development and Hydrolytic Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(1): 14-18.
3.    K. Umadevi, Mohibul Hoque1, Ramya Sri. S. Quantitative Estimation of Roxithromycin and Ambroxol in Bulk and Tablet Dosage Forms by RP-HPLC Method. Research Journal of Science and Technology 2023; 15(1): 1-7. doi: 10.52711/2349-2988.2023.00001
4.    Kapil Rana, Pushpendra Sharma. Analytical Method Development and Validation for the Simultaneous Estimation of Metformin Hydrochloride and Alogliptin by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Science and Technology. 2021; 13(2): 111-8. doi: 10.52711/2349-2988.2021.00017
5.    Akash Shelke, Someshwar Mankar, Mahesh Kolhe. Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form. Research Journal of Science and Technology. 2021; 13(2): 100-4. doi: 10.52711/2349-2988.2021.00015
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