2. VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF MELOXICAM IN ANTI-INFLAMMATORY FILM

Nguyen Van Bach1, Bui Thi Tra My1, Trinh Nam Trung1, Nguyen Truong Toan1, Nguyen Thi Hong Van1, Cao Van Anh1
1 Vietnam Military Medical University

Main Article Content

Abstract

Objective: To validate a method for the quantification of Meloxicam in film by high performance liquid chromatography in order to contribute to product quality standardization.


Subjects and methods: Quantitative Meloxicam by high performance liquid chromatography method with GRACE Apollo C18 (4.6 × 250 mm, 5 µm), flow rate 1.0 ml/min, detector UV at 354 nm, injection volume 10 µl, mobile phase consisting of acetonitril, distilled water and glacial acetic acid (55:40:5).


Results: The method ensured suitability, specificity, linearity, repeatability, and precision as specified by ICH.


Conclusions: The quantitative method meets the requirements and can be used for the quantification of Meloxicam in film.

Article Details

References

[1] Bộ Y tế, Dược thư quốc gia Việt Nam, tập 2, 2022, tr. 1074-1075.
[2] Türck D, Busch U, Heinzel G et al, Clinical pharmacokinetics of Meloxicam, Arzneimittelforschung, 1997, 47 (3), 253-258.
[3] Peter L, Klaus D, Wolfhard E et al, Structure and physicochemical properties of Meloxicam, a new NSAID, 1996, Eur. J. Pharm. Sci, 4 (3), 175-187.
[4] Aggarwal J, Singh G, Saini S et al, Fast dissolving films: A novel approach to oral drug, Internaltional research journal of pharmacy, 2011, 2 (12), 69-74.
[5] Shrimali C, Patel G, Bhimani B, Formulation and evaluation of fast dissolving oral film of Meloxicam, Internationl journal of pharmaceutical research and bio-science, 2005, 4(2), 378-387.
[6] Ankita C, Pranati S, Sunita Y et al, Fast dissolving films: A review, Current Drug Delivery, 2011, 8(4), pp. 373-380.
[7] Francine R, Luciane V, Alexandre M et al, Validation of high performance liquid chromatography method for determination of Meloxicam loaded PEGylated nanocapsules, Braz. J. Pharm. Sci, 2015, 51 (4), 823-832.
[8] Nalini K, Madhusmita S, Podilapu S et al, Validation of assay indicating method development of Meloxicam in bulk and some of its tablet dosage forms by RP-HPLC, Springerplus, 2014, 3(95), 1-6.
[9] ICH, Validation of analytical procedures: text and methodology, 2022, Q2(R2).