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Date Published: 13/01/2022
Abstract Views: 405
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DOI: https://doi.org/10.51298/vmj.v509i2.1783
Issue
Vol. 509 No. 2 (2021)
Section
Các bài báo
How to Cite
Đức Mạnh, T. ., Xuân Minh, V. ., Thị Hòa, P. ., & Văn Bạch, N. (2022). EVALUATION OF STABILITY OF VERAPAMIL HYDROCHLORIDE 120 MG SUSTAINED RELEASE CAPSULES. Vietnam Medical Journal, 509(2). https://doi.org/10.51298/vmj.v509i2.1783

EVALUATION OF STABILITY OF VERAPAMIL HYDROCHLORIDE 120 MG SUSTAINED RELEASE CAPSULES

Trương Đức Mạnh1,, Võ Xuân Minh1, Phan Thị Hòa1, Nguyễn Văn Bạch1
1 Vietnam Military Medical University

Main Article Content

Abstract

Objectives: To evaluate the stability of Verapamil hydrochloride (VER.HCl) 120 mg sustained release capsules using real-time stability testing and accelerated aging stability testing according to FDA and Asean guidelines. Methods: Quantification of VER.HCl by ultraviolet absorption spectroscopy and HPLC; evaluate the solubility of VER.HCl 120mg sustained-release capsules according to the method in USP 41; evaluate the stability of VER.HCl 120mg sustained-release capsules under real condition and accelerated aging condition (temperature 40±1oC, humidity 75%); The evaluation parameters included: pellet appearance, VER.HCl content and solubility. Results: During 18 months of storage in real condition and 6 months of storage in accelerated aging condition, the quality parameters (appearance, solubility, content) of the VER.HCl 120mg sustained-release capsules were almost constant. Conclusion: After 18 months of storage in real condition and 6 months under accelerated aging condition, the quality parameters of extended-release VER.HCl 120mg capsules were stable and passed in-house specification of product.

Article Details

Keywords

Verapamil hydrochloride, sustained release, stability

References

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