Author(s):
Manjusha Pandharinath Mhaske, Payal Sopan Gawali, Pratibha Sudhakar Bhalerao, Mahesh Hari Kolhe, Rohit Jaysingh Bhor, Ganesh Shashikant Shinde, Sudarshan Balasaheb Kakad
Email(s):
kolhe.mh@gmail.com
DOI:
10.52711/0974-360X.2025.00499 
Address:
Manjusha Pandharinath Mhaske1, Payal Sopan Gawali1, Pratibha Sudhakar Bhalerao1, Mahesh Hari Kolhe2*, Rohit Jaysingh Bhor3, Ganesh Shashikant Shinde4, Sudarshan Balasaheb Kakad5
1Department of Pharmaceutics, Pravara Rural College of Pharmacy, Prvaranagar, Loni, Maharashtra, India 413736.
2Department of Quality Assurance Techniques, Pravara Rural College of Pharmacy, Pravaranagar, Loni, Maharashtra, India. 413736.
3Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Prvaranagar, Loni, Maharashtra, India. 413736.
4Institute of Pharmacy, Loni, Maharashtra, India. 413736.
5St. John Institute of Pharmacy and Research Manor Road, Palghar, Maharashtra, India. 401404
*Corresponding Author
Published In:
Volume - 18,
Issue - 8,
Year - 2025
ABSTRACT:
Aims: This study aimed to Develope and validate a precise and reliable reverse phase high-performance liquid chromatographic (RP-HPLC) method for identification and quantification of fexofenadine hydrochloride and montelukast in both pure form and pharmaceutical formulations. Materials and Methods: Chromatographic analysis was conducted at 248nm using a DAD detector on an Agilent RP C-18 column (5µm; 4.6 x 250mm ID) with a flow rate of 0.8ml/min. A methanol-0.05% formic acid mixture (40:60 v/v) served as the mobile phase. Method validation was performed in accordance with ICH guidelines assessing linearity, accuracy, precision, and robustness. Results and Discussion: The developed method was applied to analyze both pure compounds and pharmaceutical formulations. Retention times were determined to be 4.523 for fexofenadine and 6.380 for montelukast. The method exhibited linearity across concentration ranges of 24-120µg/ml for fexofenadine and 2-10µg/ml for montelukast, with a correlation coefficient of 0.999. The relative standard deviation for six replicates was consistently below 2%. Conclusion: The RP-HPLC method developed in this study demonstrated satisfactory linearity, accuracy, precision, and robustness, making it suitable for routine quantification and identification of these drugs in both pure form and pharmaceutical formulations.
Cite this article:
Manjusha Pandharinath Mhaske, Payal Sopan Gawali, Pratibha Sudhakar Bhalerao, Mahesh Hari Kolhe, Rohit Jaysingh Bhor, Ganesh Shashikant Shinde, Sudarshan Balasaheb Kakad. Method Development and Validation of Fexofenadine and Montelukast in Pure and Pharmaceutical Formulation. Research Journal Pharmacy and Technology. 2025;18(8):3468-2. doi: 10.52711/0974-360X.2025.00499
Cite(Electronic):
Manjusha Pandharinath Mhaske, Payal Sopan Gawali, Pratibha Sudhakar Bhalerao, Mahesh Hari Kolhe, Rohit Jaysingh Bhor, Ganesh Shashikant Shinde, Sudarshan Balasaheb Kakad. Method Development and Validation of Fexofenadine and Montelukast in Pure and Pharmaceutical Formulation. Research Journal Pharmacy and Technology. 2025;18(8):3468-2. doi: 10.52711/0974-360X.2025.00499 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-8-2
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