Paladugu Venkata Naveen* and Seru Ganapaty

Department of Pharmaceutical Analysis and Quality Assurance, Gandhi Institute of Technology and Management (Deemed to be University), GITAM Institute of Pharmacy, Visakhapatnam, Andhra Pradesh, India

*Corresponding Author: Paladugu Venkata Naveen, Department of Pharmaceutical Analysis and Quality Assurance, Gandhi Institute of Technology and Management (Deemed to be University), GITAM Institute of Pharmacy, Visakhapatnam, Andhra Pradesh, India.

Received: August 18, 2021; Published: September 06, 2021

Abstract

  Luliconazole is an antifungal agent. A new stability indicating RP-UFLC method has been developed for the estimation of Luliconazole using Shimadzu UFLC system (PDA detector) with Zorbox C8 column (150 mm × 4.60 mm i.d. 5µm particle size) in bulk and pharmaceutical dosage form and validated as per ICH guidelines. A mixture of tetra butyl ammonium hydrogen sulphate and acetonitrile was used for the chromatographic separation with a flow rate of 1 mL/min. and UV detection at 220 nm. Linearity was observed over the concentration range of 0.1-100 μg/mL with linear regression equation y = 89055x - 1545.2 (R² = 0.9998). Forced degradation studies were performed and Luliconazole was found to be more sensitive towards acidic and oxidation conditions. The LOD and LOQ were found to be 0.0311 and 0.0981. The method was validated and found to be precise, accurate and robust.

Keywords: Luliconazole; Forced Degradation Studies; Validation; ICH Guidelines

References

1. Poojary SA. “A review and their role in current management of dermatophytoses”. Clinical Dermatology Review3 (2017): 24-29.
2. Deepashikha K and Subhash B. “Luliconazole for the treatment of fungal infection: an evidence based review”. Core Evidence 9 (2014): 113-124.
3. Noopur JD and Dilip GM. “UV spectrophotometric method for the estimation of Luliconazole in marketed formulation”. Pharma Science Monitor2 (2014): 48-54.
4. Sowjanya G and Mohana K. “Quantification and stability aspects of Luliconazole in bulk and pharmaceutical dosage forms by UV spectroscopy”. Journal of Drug Delivery and Therapeutics2-s (2019): 300-306.
5. Chaudhari MJ., et al. “Application of area under curve technique for UV- Spectrophotometric determination of Luliconazole in bulk and pharmaceutical formulation”. Asian Journal of Pharmaceutical Analysis1 (2018): 45-48.
6. Sultan MA., et al. “Stability indicating method for the determination of Luliconazole by TLC and HPTLC – densitometry in bulk powder and cream dosage form”. Journal of Planar Chromatography1 (2017): 68-74.
7. Santosh RT., et al. “Estimation of Luliconazole in formulation and biofluid”. Journal of Analytical and Pharmaceutical Research5 (2017): 00187.
8. Gummadi S and Kommoju M. “Development and validation of a chromatographic assay method for the determination of Luliconazole in creams”. International Journal of Pharmaceutical Sciences and Research 9 (2020): 4622-4628.
9. Tomal Majumder., et al. “Method development and validation of RP-HPLC method for estimation of Luliconazole in marketed formulation (Cream)”. Pharma Innovation 5 (2019): 103-108.
10. Palyam Bhanu., et al. “A new stability indicating RP-UFLC method for determination of Luliconazole in bulk and pharmaceutical formulation”. Research Journal of Pharmacy and Technology6 (2020): 2859-2863.
11. Aditi M and Anju G. “Method development and validation of RP HPLC method for assay and related substances of Luliconazole in topical dosage form”. International Journal of Pharmaceutical Chemistry and Analysis2 (2017): 46-50.
12. Sandeep S and Paraag G. “Application of experimental design for the optimization of forced degradation and development of a validated stability-indicating LC method for Luliconazole in bulk and cream formulation”. Arabian Journal of Chemistry2 (2016): 1428-1434.
13. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
14. ICH Stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization (2003).

Citation

Citation: Paladugu Venkata Naveen and Seru Ganapaty. “Development and Validation of a New Stability Indicating Ultra-Fast Liquid Chromatographic (RP-UFLC) Method for the Quantification of Luliconazole". Acta Scientific Pharmaceutical Sciences 5.10 (2021): 21-28.

Copyright

Copyright: © 2021 Paladugu Venkata Naveen and Seru Ganapaty. 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.