Abstract

Background: Clotrimazole is an antifungal medication that used to treat skin infection such as athlete’s foot, jock itch, ringworm and other fungal skin infection. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightning or darkening of the skin of the neck, chest, arms, or legs. It is an azole antifungal that works by preventing the growth of fungus.

Aim: To develop a combined HPLC methodology for topical formulation for determination of clotrimazole and its related impurities in a single methodology.

Method: A stability-indicating reverse phase-HPLC method has been developed and validated for the simultaneous determination of Clotrimazole in pharmaceutical dosage form. Clotrimazole was used as standard. The method was developed using a Thermo Scientific HPLC system (Ultimate 3000) with a Waters Symmetry C8 (4.6 × 150 mm I.D., 5 µm) and gradient elution consisting of Buffer and acetonitrile as the mobile phase. The flow rate was adjusted to 1.0 ml/min. The column oven was set at 40°C and the detection wavelength at 225nm. The retention times of Clotrimazole was found to be 11.817 min respectively.

Results and Discussion: The developed method was validated according to the ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the specified acceptance criteria.

Conclusion: The proposed method was successfully applied to the topical dosage form for routine analysis.

Keywords: Clotrimazole; Methyl Hydroxy Benzoate; Propyl Hydroxy Benzoate; Butylated Hydroxy Toluene Stability-Indicating; RP-HPLC; Validation

References

1. Procedure A. Method Validation Chemistry: Guidance of Industry, SIC Manufacturing and Controls Documentation, US Department of Health and Human Services. In. FDA (2000).
2. Cartwright RY. “Clotrimazole in the Treatment of Acute and "Resistant" Vaginal Candidiasis”. Postgraduate Medical Journal 50 (1974): 90-92.
3. Basavaiah Kanakapura and Vamsi Krishna Penmatsa. “Analytical methods for determination of terbinafinehydrochloride in pharmaceuticals and biological materials”. Journal of Pharmaceutical Analysis3 (2016):137-149.
4. Dunster GD. “Vaginal candidiasis in pregnancy- A trial of clotrimazole”. Postgraduate Medical Journal1 (1974): 86-88.
5. Mahmood S., et al. “Method development and validation for estimation and evaluation of clotrimazole (an antifungal drug) in tablet preparation by UV-Vis spectroscopy”. International Journal of Pharmaceutical Sciences Review and Research 2 (2015): 55-58.
6. Zhang L., et al. “Dermal Targeting Delivery of Clotrimazole Using Novel Multi-Ethosomes: A New Approach to Fungal Infection Treatment”. Coatings4 (2020): 304.
7. “Development and Validation of Analytical Methods for Simultaneous Estimation of Clotrimazole in Bulk and tablet formulation”. Indian Journal of Pharmaceutical Sciences4 (2018): 451-454.
8. Ich Harmonised Tripartite Guideline. “Validation Of Analytical Procedures: Text And Methodology Q2(R1)” (1994).
9. Dantus MM and Wells ML. “Regulatory issues in Chromatographic analysis in the pharmaceutical industry”. Journal of Liquid Chromatography and Related Technologies 7-9 (2004): 1413-1442.
10. Directorate-General for Consumer Safety, European Union (2011). "Scientific Committee on Consumer Safety Opinion on Parabens COLIPA n° P82" (2011).
11. ChEBl Clotrimazole.
12. ChEBI Ontology.
13. Article on Analytical method development and validation for simultaneous Estimation of Clotrimazole and its preservative and antioxidant.

Citation

Citation: Parag Das., et al. “A Rapid RP-HPLC Methodology for the Determination of Clotrimazole Impurities in Topical Dosage Forms". Acta Scientific Pharmaceutical Sciences 5.1 (2021): 97-107.

Copyright

Copyright: © 2021 Parag Das., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.