Parag Das1*, Kumar Khatri2, Ankit Gangani2 and Animesh Maity1
1Oman Pharmaceutical Products Co. LLC, Muscat, Sultanate of Oman, Oman
2Hamlai Industries Pvt. Ltd., Sanand, Ahmedabad, Gujarat, India
*Corresponding Author: Parag Das, Vice President – Technical, Oman Pharmaceutical Products Co. LLC Muscat, Sultanate of Oman, Oman.
Received: October 14, 2020; Published: December 28, 2020
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
Citation: Parag Das., et al. “Combined RP-HPLC Methodology for the Determination of Clotrimazole and its Impurities in Topical Formulations". Acta Scientific Pharmaceutical Sciences 5.1 (2021): 97-107.
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.