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

International Journal of Analytical Chemistry
Mohyeddin AssaliNoura Ghazal

Abstract

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. 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 robu...Continue Reading

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Methods Mentioned

BETA
NMR

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