Author(s):
Moein S. Attar, Ram S. Sakhare, Vivek B. Panchbhai, Vijayendra Swamy S. M., Vaishnavi R. Khandade
Email(s):
moinattar@gmail.com
DOI:
10.52711/2231-5659.2026.00018
Address:
Moein S. Attar1*, Ram S. Sakhare2, Vivek B. Panchbhai3, Vijayendra Swamy S. M.4, Vaishnavi R. Khandade5
1Research Scholar, Channabasweshwar Pharmacy College (Degree), Latur, Affiliated to SRTMU Nanded, Maharashtra, India.
2Head, Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College (Degree), Latur, Maharashtra, India.
3Head, Department of Pharmaceutical Chemistry, Channabasweshwar Pharmacy College (Degree), Latur, Maharashtra, India.
4Principal, Channabasweshwar Pharmacy College (Degree), Latur, Maharashtra, India.
5Research Student, Channabasweshwar Pharmacy College (Degree), Latur, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 2,
Year - 2026
ABSTRACT:
An efficient and cost-effective RP-HPLC method was optimized for the concurrent quantification of fluconazole and terbinafine in combined tablet formulations. Separation was accomplished on a Discovery C18 column (150 × 4.6mm, 5µm) using a mobile phase comprising 0.01N sodium hydrogen phosphate buffer and acetonitrile (70:30 v/v), delivered at 1.2mL/min under isothermal conditions (30°C). UV detection at 246nm yielded distinct retention times of 2.16 min for fluconazole and 3.09 min for terbinafine. The method demonstrated high precision (%RSD < 0.5), excellent recovery (99.69% for fluconazole and 100.15% for terbinafine), and low detection limits (0.52µg/mL and 0.17µg/mL, respectively). Linearity was confirmed with correlation coefficients exceeding 0.999. The rapid analysis and reduced solvent consumption render this method highly suitable for routine quality control in pharmaceutical settings.
Cite this article:
Moein S. Attar, Ram S. Sakhare, Vivek B. Panchbhai, Vijayendra Swamy S. M., Vaishnavi R. Khandade. Validated Stability Indicating RP HPLC Method for the Dual Drug Analysis of Fluconazole and Terbinafine in Solid Oral Dosage Forms. Asian Journal of Research in Pharmaceutical Sciences.2026; 16(2):111-6. doi: 10.52711/2231-5659.2026.00018
Cite(Electronic):
Moein S. Attar, Ram S. Sakhare, Vivek B. Panchbhai, Vijayendra Swamy S. M., Vaishnavi R. Khandade. Validated Stability Indicating RP HPLC Method for the Dual Drug Analysis of Fluconazole and Terbinafine in Solid Oral Dosage Forms. Asian Journal of Research in Pharmaceutical Sciences.2026; 16(2):111-6. doi: 10.52711/2231-5659.2026.00018 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2026-16-2-3
REFERENCES:
1. Fda, Cder, Beers, Donald. Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry [Internet]. 2015. Available from: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orhttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
2. Sonawane JK, Chavan SM, Narkar IP, Jale SC, Tendulkar NV, Jadhav ProfV, et al. A Review of Stability Indicating Methods and Forced Degradation Studies. Int J Res Publ Rev [Internet]. 2023 June [cited 2025 Sept 8]; 4(5): 4703–15. Available from: https:// ijrpr.com/uploads/V4ISSUE5/IJRPR13399.pdf
3. ICH_Q2-R2_Document_Step2_Guideline_2022_0324.
4. Swapna J, Madhu C, Srivani M, Sumalatha M, Nehalatha Y, Anusha Y. Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. 2(3).
5. Kumar I, Singh I, Kumar Verma K, Dhiman S, Palia P. Therapeutic Potential of Naturally Modified Mucoadhesive Fluconazole Tablets against Vaginal Infection. AJPT [Internet]. 2023 May 30 [cited 2025 Sept 8];101–4. Available from: https://ajptonline.com/AbstractView.aspx?PID=2023-13-2-5
6. Roshdy A, Elmansi H, Shalan S, El-Brashy A. Factorial design-assisted reversed phase-high performance liquid chromatography method for simultaneous determination of fluconazole, itraconazole and terbinafine. R Soc open sci [Internet]. 2021 Feb [cited 2025 Sept 8]; 8(2): rsos.202130, 202130. Available from: https://royalsocietypublishing.org/doi/10.1098/rsos.202130
7. Salve PS. Development and evaluation of topical drug delivery system for terbinafine hydrochloride using niosomes. 2011;
8. Debnath S, Kumar GV, Satyanarayana SV. Preparation and Evaluation of Solid Dispersion of Terbinafine Hydrochloride. 3(1).
9. Karanam SR, Swarupa VRJ. Stability Indicating Analytical Method Development and Validation for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form. Asian Jour Pharmac Anal [Internet]. 2016 [cited 2025 Sept 8]; 6(1): 7. Available from: http://www.indianjournals.com/ ijor.aspx?target=ijor:ajpa&volume=6&issue=1&article=002
10. Bhavya B, Nagaraju P, Mounika V, Priyadarshini GI. Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Albendazole and Ivermectin in Pharmaceutical Dosage form. Asian Jour Pharmac Anal [Internet]. 2017 [cited 2025 Sept 8]; 7(1): 6. Available from: http://www.indianjournals.com/ijor.aspx?target=ijor:ajpa&volume=7&issue=1&article=002
11. Shelke A, Mankar S, Kolhe M. Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form. RJST [Internet]. 2021 May 17 [cited 2025 Sept 8]; 100–4. Available from: https://rjstonline.com/ AbstractView.aspx?PID=2021-13-2-6
12. Gayatri LA, Amol S, Indrajeet S. Development and Validation of A Stability-Indicating RP-HPLC Method for the Determination of Sitagliptin Phosphate and Simvastatin in the Presence of their Degradation Products in Bulk and Binary Mixture. Asia Journ of Resear in Pharmac Scie [Internet]. 2016 [cited 2025 Sept 8]; 6(3): 191. Available from: http://www.indianjournals.com/ ijor.aspx?target=ijor:ajrps&volume=6&issue=3&article=008
13. ICH_Q2(R2) Guideline_2023_1130.
14. Mansi P. Rana. Overview Of Degradation Studies For Pharmaceutical Drug Candidates. 2024 Apr 3 [cited 2025 Sept 8]; Available from: https://zenodo.org/doi/10.5281/zenodo.10913401
15. Jatte KP, Chakole RD, Charde MS. Degradation Profiling of Lisinopril and Hydrochlorothiazide by RP- HPLC method with QbD Approach. Asian Journal of Pharmaceutical Analysis. 2021 Nov; 270–4.
16. Dulange V, Gajeli GB. Development and Validation of UV Spectroscopy Method for the Estimation of Dolutegravir in Bulk and Pharmaceutical Dosage Form. AJPA [Internet]. 2021 Aug 16 [cited 2025 Aug 6]; 188–90. Available from: https:// ajpaonline.com/AbstractView.aspx?PID=2021-11-3-2