Development of quantitation method for Acyclovir in tablet of known manufacturing formula using Raman spectroscopy

Thi Thuy Truong1, Dinh Chi Le2, Hoang Tran1, Van Trung Bui1, , Thi La Le1, Thi Bich Van Tran1
1 National Institute of Drug Quality Control
2 Ha Noi University of Pharmacy

Main Article Content

Abstract

A fast, simple, nondestructive method using Raman spectrometers was developed for quantitation of acyclovir (ACV) in tablet powder with known composition. The method employed spectra of reference mixture containing from 30% to 84% ACV (w/w) recorded in wavenumber region from 150 cm-1 to 2800 cm-1 to build PLS assay model using 4 factors. Raman spectra of the tabets were pre-processed in the wavebands of 320 cm-1 to 520 cm-1, 820 cm-1 to 900 cm-1 and 1000 cm-1 to 1200 cm-1 combined with partial least squares (PLS) regression to establish a quantitative model. The method was validated according to current international requirements on performance of analytical method, and was proven to have specificity, linearity, accuracy, and precision.

Article Details

References

1. King DH (1988), “History, pharmacokinetics, and pharmacology of ACV”, Journal of the American Academy of Dermatology, 18 (1 Pt 2), pp. 176-9.
2. Cục Quản lý Dược, Bộ Y tế, truy cập ngày 05/03/2025, tại trang web https://dichvucong.dav.gov.vn/congbothuoc/index.
3. Bộ Y tế (2022), Dược thư quốc gia Việt Nam, tr.131-134, Nhà xuất bản Khoa học và kỹ thuật, Hà Nội.
4. USP-NF ACV Tablets, truy cập ngày 05/03/2025, tại trang web https://online.uspnf.com/uspnf/document/1_GUID-F88C3838-A620-406E-BE1D-153B9FB9EC3D_1_en-US source=Search%20Results&highlight=ACV.
5. Skoulika S. G., Georgiou C. A. (2003), “Rapid, noninvasive quantitative determination of acyclovir in pharmaceutical solid dosage forms through their poly(vinyl chloride) blister package by solid-state Fourier transform Raman spectroscopy”, Applied Spectroscopy, 57(4), pp. 407-12
6. ICH (1996), Validation of Analytical Procedures: Text and Methodology Q2 (R1).
7. AOAC International (2016), Appendix F:Guidelines for Standard Method Performance Requirements, AOAC Official Methods.
8. EMA (2014), Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations.