Quantification and stability aspects of Luliconazole in bulk and pharmaceutical dosage forms by UV spectroscopy
UV for Luliconazole
Two simple and economical UV spectroscopic methods were developed for the estimation of Luliconazole in creams. The drug showed maximum absorption at 294 nm, both in 0.1N HCl and phosphate buffer (pH 2.0) in the fundamental spectra (D0). The same spectra were derivatized into first derivative (D1) and the dA/dλ was measured at 315 nm in 0.1N HCl and 317 nm in phosphate buffer (pH 2.0). In both the methods the drug obeyed Beer-Lambert’s law in the concentration range of 2-30 μg/mL in 0.1N HCl and 10-30 μg/mL in phosphate buffer (pH 2.0). The linear regression equations were calculated to be y = 0.0504x + 0.0102 (R2 = 0.9991) for D0 and y = 0.0025x + 0.0002 (R2 = 0.9991) for D1 in 0.1N HCl, y = 0.0637x + 0.0181 (R2 = 0.999) for D0 and y = 0.0025x + 0.0006 (R2 = 0.999) for D1 in phosphate buffer (pH 2.0). An acceptable recovery in the range of 98 ± 0.01 – 102 ± 0.001 % indicates accuracy as well as non-interference from excipients in the present method. The intraday and inter day precision results were within 2 % RSD indicating the preciseness of the methods. The methods were applied for quantification of Luliconazole in marketed creams and the assay was obtained as 98.53 % w/w against the label claim. The methods were also applied to study the stability aspects of the drug in a variety of conditions like acid, base and oxidative stress along with thermal and photolytic stress conditions. The drug showed altered absorbance in basic and photolysis conditions. The methods were validated statistically as per the ICH guidelines.
Keywords: Luliconazole, UV spectroscopy, Stability, Validation, ICH.
2. Jarrett M, Jones T, Kempers S, Rich P, Morton K, Nakamura N, Tavakkol. A Luliconazole for the treatment of interdigital tinea pedis; A double-blind, vehicle-controlled study. Cutis, (2013); 91:203-10.
3. Drake LA, Dincehart SM, Farmer ER. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. J Am Acad Dermatol, (1996); 34:282-6.
4. Uchida K, Nishiyama Y, Tanaka T, Yamaguchi H. In vitro activity of novel imidazole antifungal agent NND-502 against Malassezia species. Int J Antimicrob Agents, (2003); 21:234–8.
5. Koga H, Nanjoh Y, Makimura K. In vitro antifungal activities of Luliconazole, a new topical imidazole. Med Mycol, (2009); 47:640-7.
6. US Food and Drug Administration. Center for Drug Evaluation and Research. Application Number 204153Orig1s000: Clinical Pharmacology and Biopharmaceutics Review. From FDA website.
7. Marek A Wolter M. K. Leahy L. Geisler, N. Nakamura. Development of an LC-MS/MS Method for the Determination of the Antifungal Luliconazole in Human Toenails. American Association of Pharmaceutical Scientists, DOI:10.13140/RG.2.2.22476.51847. (2013).
8. Malasiya A, Goyal A. 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 Analysis, (2017); 4(2):46-50.
9. SRTambe, Sawanth SD, Bhonsle AP. Estimation of Luliconazole in Formulation and Biofluid. J Anal Pharm Res, (2017); 6(5): 00187.
10. Chaudhari MJ, Chaudhari SR, Chalikwar SC, Shirkhedkar AA. Application of area under curve technique for UV- Spectrophotometric determination of Luliconazole in bulk and pharmaceutical formulation. Asian J. Pharm. Ana, (2018); 8(1):45-48.
11. ICH validation of analytical procedures: text and methodology Q2 (R1), International Conference on Harmonization, 2005.
12. ICH stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization, 2003.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (SeeÂ The Effect of Open Access).