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Green HPLC method for simultaneous determination of N-acetylcysteine and L-ascorbic acid in co-formulated pharmaceutical products

Year 2024, Volume: 28 Issue: 5, 1777 - 1790, 28.06.2025

Gürkan Özen , Emirhan Nemutlu

Abstract

It is difficult to analyze different concentrations of pharmaceutical active substances in dosage forms simultaneously, especially in formulations containing high amounts of excipients, on environmentally friendly principles without the need for any intervention. This study proposes a powerful analytical method for the simultaneous determination of L-ascorbic Acid and N- Acetyl Cysteine in an effervescent tablet using high performance liquid chromatography technique. In the study, it was aimed to reduce the use of toxic solvents/chemicals and waste emissions, to increase efficiency and to reduce the negative environmental consequences that may arise from them. The method was developed using a C18 (ACE-121-2546, 4.6 x 250 mm, 5 µm) column and a sodium dihydrogen phosphate buffer mobile phase. Detection wavelengths were taken as 210 and 240 nm while the flow rate was 1 mL/min. The linearity, accuracy and precision, selectivity, sensitivity, and robustness of the proposed method were validated using International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q2R criteria and its green assessment was validated by AGREE and AGREEprep applications. The linear range was taken as 0.1-100 μg/mL for both compounds analyzed in the developed method. The detection limit of the method was 0.02 and 0.04 µg/mL respectively for L-ascorbic Acid and N- Acetyl Cysteine. The recovery of the method was between 98.75%- 102.20% and the accuracy and precision of the method for all compounds were 0.17% and 0.11% respectively. This new environmentally friendly method can be easily used by the chemical and pharmaceutical industries for regular analysis without any restrictions.

Keywords

Stability indicating HPLC Ascorbic acid Acetyl cysteine Determination Validation Effervescent tablet

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There are 53 citations in total.

Details

Primary Language English
Subjects Pharmaceutical Analytical Chemistry
Journal Section Articles
Authors

Gürkan Özen 0000-0003-0777-6402

Emirhan Nemutlu 0000-0002-7337-6215

Publication Date June 28, 2025
Submission Date March 11, 2024
Acceptance Date May 17, 2024
Published in Issue Year 2024 Volume: 28 Issue: 5

Cite

APA Özen, G., & Nemutlu, E. (2025). Green HPLC method for simultaneous determination of N-acetylcysteine and L-ascorbic acid in co-formulated pharmaceutical products. Journal of Research in Pharmacy, 28(5), 1777-1790.
AMA Özen G, Nemutlu E. Green HPLC method for simultaneous determination of N-acetylcysteine and L-ascorbic acid in co-formulated pharmaceutical products. J. Res. Pharm. July 2025;28(5):1777-1790.
Chicago Özen, Gürkan, and Emirhan Nemutlu. “Green HPLC Method for Simultaneous Determination of N-Acetylcysteine and L-Ascorbic Acid in Co-Formulated Pharmaceutical Products”. Journal of Research in Pharmacy 28, no. 5 (July 2025): 1777-90.
EndNote Özen G, Nemutlu E (July 1, 2025) Green HPLC method for simultaneous determination of N-acetylcysteine and L-ascorbic acid in co-formulated pharmaceutical products. Journal of Research in Pharmacy 28 5 1777–1790.
IEEE G. Özen and E. Nemutlu, “Green HPLC method for simultaneous determination of N-acetylcysteine and L-ascorbic acid in co-formulated pharmaceutical products”, J. Res. Pharm., vol. 28, no. 5, pp. 1777–1790, 2025.
ISNAD Özen, Gürkan - Nemutlu, Emirhan. “Green HPLC Method for Simultaneous Determination of N-Acetylcysteine and L-Ascorbic Acid in Co-Formulated Pharmaceutical Products”. Journal of Research in Pharmacy 28/5 (July 2025), 1777-1790.
JAMA Özen G, Nemutlu E. Green HPLC method for simultaneous determination of N-acetylcysteine and L-ascorbic acid in co-formulated pharmaceutical products. J. Res. Pharm. 2025;28:1777–1790.
MLA Özen, Gürkan and Emirhan Nemutlu. “Green HPLC Method for Simultaneous Determination of N-Acetylcysteine and L-Ascorbic Acid in Co-Formulated Pharmaceutical Products”. Journal of Research in Pharmacy, vol. 28, no. 5, 2025, pp. 1777-90.
Vancouver Özen G, Nemutlu E. Green HPLC method for simultaneous determination of N-acetylcysteine and L-ascorbic acid in co-formulated pharmaceutical products. J. Res. Pharm. 2025;28(5):1777-90.