RP-HPLC Method Development and Validation of Synthesized Codrug in Combination with Indomethacin, Paracetamol, and Famotidine

Joint Authors

Abualhasan, Murad N.
Assali, Mohyeddin
Zohud, Nihal
Ghazal, Noura

Source

International Journal of Analytical Chemistry

Issue

Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-9, 9 p.

Publisher

Hindawi Publishing Corporation

Publication Date

2020-07-01

Country of Publication

Egypt

No. of Pages

9

Main Subjects

Chemistry
Science

Abstract EN

Background.

Indomethacin is considered a potent nonsteroidal anti-inflammatory drug that could be combined with Paracetamol to have superior and synergist activity to manage pain and inflammation.

To reduce the gastric side effect, they could be combined with Famotidine.

Methodology.

A codrug of Indomethacin and Paracetamol was synthesized and combined in solution with Famotidine.

The quantification of the pharmaceutically active ingredients is pivotal in the development of pharmaceutical formulations.

Therefore, a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated according to the International Council for Harmonization (ICH) Q2R1 guidelines.

A reverse phase C18 column with a mobile phase acetonitrile: sodium acetate buffer 60 : 40 at a flow rate of 1.4 mL/min and pH 5 was utilized.

Results.

The developed method showed good separation of the four tested drugs with a linear range of 0.01–0.1 mg/mL (R2 > 0.99).

The LODs for FAM, PAR, IND, and codrug were 3.076 × 10−9, 3.868 × 10−10, 1.066 × 10−9, and 4.402 × 10−9 mg/mL respectively.

While the LOQs were 9.322 × 10−9, 1.172 × 10−10, 3.232 × 10−9, and 1.334 × 10−8 mg/mL, respectively.

Furthermore, the method was precise, accurate, selective, and robust with values of relative standard deviation (RSD) less than 2%.

Moreover, the developed method was applied to study the in vitro hydrolysis and conversion of codrug into Indomethacin and Paracetamol.

Conclusion.

The codrug of Indomethacin and Paracetamol was successfully synthesized for the first time.

Moreover, the developed analytical method, to our knowledge, is the first of its kind to simultaneously quantify four solutions containing the following active ingredients of codrug, Indomethacin, Paracetamol, and Famotidine mixture with added pharmaceutical inactive ingredients in one HPLC run.

American Psychological Association (APA)

Assali, Mohyeddin& Abualhasan, Murad N.& Zohud, Nihal& Ghazal, Noura. 2020. RP-HPLC Method Development and Validation of Synthesized Codrug in Combination with Indomethacin, Paracetamol, and Famotidine. International Journal of Analytical Chemistry،Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1167593

Modern Language Association (MLA)

Abualhasan, Murad N.…[et al.]. RP-HPLC Method Development and Validation of Synthesized Codrug in Combination with Indomethacin, Paracetamol, and Famotidine. International Journal of Analytical Chemistry No. 2020 (2020), pp.1-9.
https://search.emarefa.net/detail/BIM-1167593

American Medical Association (AMA)

Assali, Mohyeddin& Abualhasan, Murad N.& Zohud, Nihal& Ghazal, Noura. RP-HPLC Method Development and Validation of Synthesized Codrug in Combination with Indomethacin, Paracetamol, and Famotidine. International Journal of Analytical Chemistry. 2020. Vol. 2020, no. 2020, pp.1-9.
https://search.emarefa.net/detail/BIM-1167593

Data Type

Journal Articles

Language

English

Notes

Includes bibliographical references

Record ID

BIM-1167593