Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation.

Autor: Rapalli VK; Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science (BITS), Pilani, India., Singhvi G; Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science (BITS), Pilani, India., Gorantla S; Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science (BITS), Pilani, India., Waghule T; Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science (BITS), Pilani, India., Dubey SK; Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science (BITS), Pilani, India., Saha RN; Industrial Research Laboratory, Department of Pharmacy, Birla Institute of Technology and Science (BITS), Pilani, India.; Birla Institute of Technology and Science (BITS) Pilani, Dubai Campus, Dubai, UAE., Hasnain MS; Department of Pharmacy, Shri Venkateshwara University, Gajraula, India., Nayak AK; Department of Pharmaceutics, Seemanta Institute of Pharmaceutical Sciences, Mayurbhanj, India.
Jazyk: angličtina
Zdroj: Journal of separation science [J Sep Sci] 2019 Nov; Vol. 42 (22), pp. 3413-3420. Date of Electronic Publication: 2019 Oct 01.
DOI: 10.1002/jssc.201900538
Abstrakt: Low-potency corticosteroid betamethasone valerate and vitamin-A tazarotene are used in combination for effective treatment of psoriasis. There is no robust high-performance liquid chromatography analytical technique available for simultaneous estimation of betamethasone valerate and tazarotene in conventional and nanocarriers based formulations. A simple, accurate, robust isocratic high-performance liquid chromatography method was developed for simultaneous estimation of betamethasone valerate and tazarotene in topical pharmaceutical formulations. The developed method was validated as per the regulatory guidelines. The validated method was linear over the concentration range of 150-6000 ng/mL (r 2  > 0.999) at 239 nm wavelength. Limits of detection and quantification of two analytes were 50 and 150 ng/mL, respectively. The %relative standard deviation for intraday and interday precision was less than 2%. The method was also evaluated in the presence of forced degradation conditions. The developed method was successfully applied for in vitro and ex vivo drug release studies of in-house designed nanoformulations.
(© 2019 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)
Databáze: MEDLINE
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