Author(s):
Payal Sopan Gawali, Manjusha Pandharinath Mhaske, Pratibha Sudhakar Bhalerao, Mahesh Hari Kolhe, Ganesh Shashikant Shinde, Rohit Jaysingh Bhor, Sanket Keshav Tambe
Email(s):
kolhe.mh@gmail.com
DOI:
10.52711/0974-360X.2026.00091 
Address:
Payal Sopan Gawali1, Manjusha Pandharinath Mhaske1, Pratibha Sudhakar Bhalerao1, Mahesh Hari Kolhe2*, Ganesh Shashikant Shinde3, Rohit Jaysingh Bhor4, Sanket Keshav Tambe4
1Department of Pharmaceutics, Pravara Rural College of Pharmacy, Pravaranagar, Loni, Maharashtra, India-413736.
2Department of Quality Assurance Techniques, Pravara Rural College of Pharmacy, Pravaranagar, Loni, Maharashtra, India-413736.
3Institute of Pharmacy, Loni, Maharashtra, India-413736.
4Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Pravaranagar, Loni, Maharashtra, India-413736.
*Corresponding Author
Published In:
Volume - 19,
Issue - 2,
Year - 2026
ABSTRACT:
Objective: The primary objective of this work is to develop and validate a simple, reliable, and sensitive technique for the analysis of fexofenadine hydrochloride and montelukast and to use the proposed method for the analysis of the drugs in pharmaceutical dosage forms. Materials and Method: Chromatographic separation of fexofenadine hydrochloride and montelukast was carried out using Agilent RP C-18 (5µm; 4.6 x 250 mm ID) column having mobile phase Methanol and 0.05%Formic acid in a ratio of 40:60v/v with 0.8ml/min flow rate. Wavelength used throughout study was 248nm with DAD detector at 26oC. Result and Discussion: Newly developed method and forced degradation study was carried out as per the ICH guidelines. The proposed method effectively identifies and quantify the drug in the formulation. The linearity of this method was found within the range of 24-120µg/ml and 2-10µg/ml for fexofenadine and montelukast respectively. For six replicates, the relative standard deviation is always less than 2%.In forced degradation study the drugs shows the maximum degradation in acidic condition. Conclusion: From the study results of recovery, robustness, accuracy, precision, linearity and specificity of the proposed stability-indicating RP-HPLC technique for fexofenadine and montelukast is suitable for precise identification and quantification in combined formulation and can be used in routine analysis.
Cite this article:
Payal Sopan Gawali, Manjusha Pandharinath Mhaske, Pratibha Sudhakar Bhalerao, Mahesh Hari Kolhe, Ganesh Shashikant Shinde, Rohit Jaysingh Bhor, Sanket Keshav Tambe. Stability Indicating Method Development and Validation of Fexofenadine and Montelukast in Pure and Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2026;19(2):625-0. doi: 10.52711/0974-360X.2026.00091
Cite(Electronic):
Payal Sopan Gawali, Manjusha Pandharinath Mhaske, Pratibha Sudhakar Bhalerao, Mahesh Hari Kolhe, Ganesh Shashikant Shinde, Rohit Jaysingh Bhor, Sanket Keshav Tambe. Stability Indicating Method Development and Validation of Fexofenadine and Montelukast in Pure and Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2026;19(2):625-0. doi: 10.52711/0974-360X.2026.00091 Available on: https://rjptonline.org/AbstractView.aspx?PID=2026-19-2-20
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