Current Trends in Pharmacy and Pharmaceutical Chemistry

Online ISSN: 2582-5062

Current Trends in Pharmacy and Pharmaceutical Chemistry is the official Journal of Ateos Foundation of Science Education and Research, hosted and Managed IP Innovative Publications Pvt. Ltd, New Delhi, India. Current Trends in Pharmacy and Pharmaceutical Chemistry is an open access, peer-reviewed quarterly international journal publishing since 2019 and is published under auspices of the Ateos Foundation of Science Education and Research. It aims to uplift researchers, scholars, academicians, and professionals in all academic and scientific disciplines. more...

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Original Article


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114-121


Authors Details

Vaibhav S. Adhao*, Jaya P. Ambhore, Anant D. Bhuskat, Dishali V. Talokar


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Comparative in-Vitro dissolution study of some sitagliptin generic tablets under biowaiver conditions by UV-Spectroscopy


Original Article

Author Details : Vaibhav S. Adhao*, Jaya P. Ambhore, Anant D. Bhuskat, Dishali V. Talokar

Volume : 6, Issue : 3, Year : 2024

Article Page : 114-121

https://doi.org/10.18231/j.ctppc.2024.025



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Abstract

Purpose: The objective of this study is to evaluate the bioequivalence of generic sitagliptin tablets from different manufacturers using in-vitro dissolution study under biowaiver conditions through UV Spectroscopy, and compare them with the innovator brand.
Materials and Methods: The dissolution media consisted of three different buffers with varying pH levels, including HCl Buffer pH 2.0, Phosphate Buffer pH 4.0, and Phosphate Buffer pH 7.2. The dissolution process was conducted using a USP type-2 dissolution apparatus with a 900 ml basket. The rotational speed of the paddle was set at 50 RPM, while maintaining a temperature of 37.5°C +/- 2°C. Samples were collected at four different intervals as recommended by the USFDA, which were 15, 30, 45, and 60 minutes.
Results: Validation parameters such as Accuracy, Precision, Linearity, LOD, and LOQ were assessed. The dissolution profiles exhibited no significant variability between different brands and within the same brand. Furthermore, the dissolution results of all tablet formulations, including the innovator brand, were analysed using the difference factor (f1) and similarity factor (f2).
The findings from this study indicate that both generic brands of sitagliptin tablets meet the USFDA dissolution specifications and can be considered interchangeable.


Keywords: Sitagliptin, Dissolution study, Biowaiver, Antidiabetic, Bioequivalence, UV spectroscopy


How to cite : Adhao V S, Ambhore J P, Bhuskat A D, Talokar D V, Comparative in-Vitro dissolution study of some sitagliptin generic tablets under biowaiver conditions by UV-Spectroscopy. Curr Trends Pharm Pharm Chem 2024;6(3):114-121

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