Advances in Pharmacology and Pharmacy Vol. 13(1), pp. 37 - 49
DOI: 10.13189/app.2025.130105
Reprint (PDF) (1195Kb)

B. Sharannavar 1,*, M. Bhagat Amonkar 1, Apurva Deo 1, Shailendra Suryawanshi 2, Nithyanand Sastry Darbha 3
1 Department of Pharmaceutical Quality Assurance, KLE College of Pharmacy, KLE Academy of Higher Education and Research, JNMC Campus, India
2 Department of Pharmaceutical Chemistry, KLE College of Pharmacy, KLE Academy of Higher Education and Research, JNMC Campus, India
3 Department of Pharmacognosy, KLE College of Pharmacy, KLE Academy of Higher Education and Research, JNMC Campus, India

ABSTRACT

Minoxidil is an anti-hypertensive agent and Tofacitinib citrate is a Janus-kinase inhibitor but there are various articles proving their efficacy in the treatment of Alopecia. An effort is made in order to formulate gel for topical use containing Minoxidil and Tofacitinib citrate for the treatment of Alopecia areata. Objective: The aim of study is to establish and validate a sensitive, selective and precise, method capable of accurately detecting Minoxidil and Tofacitinib citrate in both their raw form and pharmaceutical formulations, adhering strictly to the guidelines outlined by the International Council for Harmonisation (ICH). Method: A UV-spectrophotometric method was devised to simultaneously determine the concentrations of Minoxidil and Tofacitinib citrate. The method underwent validation across various parameters including Linearity, Accuracy, Precision, Repeatability, LOD, LOQ, Robustness, and Ruggedness. A double-beam UV-spectrophotometric technique was developed to simultaneous estimation of the levels of Minoxidil and Tofacitinib citrate. This method was then rigorously validated using various parameters including linearity, accuracy, precision, repeatability, detection limit (LOD), quantification limit (LOQ), robustness, and ruggedness. Results: In the Methanol solvent, Minoxidil exhibits its peak absorbance at 258nm, while Tofacitinib citrate displays its maximum absorbance at 290nm. The concentration range of 2-10µg/mL for both analytes adheres to Beer's law, indicating their reliable quantification potential. For Minoxidil, the Limits of Detection (LOD) and Limits of Quantification (LOQ) stand at 0.537µg/mL and 1.628µg/mL, respectively. Tofacitinib citrate, on the other hand, exhibits LOD and LOQ values of 0.427µg/mL and 1.294µg/mL, respectively. In the assessment of their presence in a topical gel formulation, recovery rates ranging from 50.00% to 150.00% were observed for both Minoxidil and Tofacitinib citrate. Conclusion: The method proposed demonstrates selectivity, specificity, precision, accuracy, ruggedness, and robustness, rendering it suitable for routine analysis of Minoxidil and Tofacitinib citrate in both bulk form and pharmaceutical dosage formulations.

KEYWORDS
Minoxidil, Tofacitinib Citrate, Anti-hypertensive, Janus Kinase Inhibitor, ICH Guidelines, UV-spectrophotometric

Cite This Paper in IEEE or APA Citation Styles
(a). IEEE Format:
[1] B. Sharannavar , M. Bhagat Amonkar , Apurva Deo , Shailendra Suryawanshi , Nithyanand Sastry Darbha , "Simultaneous Estimation of Minoxidil and Tofacitinib Citrate in Bulk and Topical Gel - A Validated UV-spectrophotometric Technique," Advances in Pharmacology and Pharmacy, Vol. 13, No. 1, pp. 37 - 49, 2025. DOI: 10.13189/app.2025.130105.

(b). APA Format:
B. Sharannavar , M. Bhagat Amonkar , Apurva Deo , Shailendra Suryawanshi , Nithyanand Sastry Darbha (2025). Simultaneous Estimation of Minoxidil and Tofacitinib Citrate in Bulk and Topical Gel - A Validated UV-spectrophotometric Technique. Advances in Pharmacology and Pharmacy, 13(1), 37 - 49. DOI: 10.13189/app.2025.130105.