Simultaneous Determination of Metformin, Cimetidine, Famotidine, and Ranitidine in Human Serum and Dosage Formulations Using HPLC with UV Detection

• Published in: Journal of chromatographic science Vol. 48; no. 9; pp. 721 - 725
• Main Authors: Arayne, M. Saeed, Sultana, Najma, Zuberi, M. Hashim, Siddiqui, Farhan Ahmed
• Format: Journal Article
• Language: English
• Published: Niles, IL Oxford University Press 01.10.2010; Preston Publications
• Subjects: Adult; Analysis; Biological and medical sciences; Chromatography, High Pressure Liquid - methods; Cimetidine - blood; Ethylamines - chemistry; Famotidine - blood; General pharmacology; Histamine H2 Antagonists - blood; Humans; Hydrogen-Ion Concentration; Linear Models; Medical sciences; Metformin - blood; Methanol - chemistry; Pharmacology. Drug treatments; Ranitidine - blood; Reproducibility of Results; Sensitivity and Specificity; Spectrophotometry, Ultraviolet - methods; Tablets - chemistry; Young Adult; Biological fluid; Chemical analysis; HPLC chromatography; Antiulcer agent; Antihistaminic; Blood; Hypoglycemic agent; Biguanides; Antisecretory agent; Tablet; Antagonist; Quantitative analysis; Human; Validation; Cimetidine; Oral form; Famotidine; Reversed phase chromatography; Ultraviolet detector; Simultaneous measurement; Ranitidine; Dosage form; Metformin; Blood serum; H2 Histamine receptor
• ISSN: 0021-9665; 1945-239X
• DOI: 10.1093/chromsci/48.9.721

A new, simple, and reliable reversed-phase high-performance liquid chromatographic method has been developed and validated for the simultaneous determination of metformin (Metf), cimetidine (Cimt), famotidine (Famt), and ranitidine (Rant) in their synthetic mixtures and tablet formulations. These drugs were separated on a Purospher Star RP18 endcapped (250 mm × 4.6 mm i.d.) column packed with 5-µm particles. The mobile phase, optimized through an experimental design, consisted of methanol-water-triethylamine (20:80:0.05), whose pH was adjusted to 3.0 with phosphoric acid (85%) pumped at a flow rate of 1.0 mL/min. UV detection was performed at 229 nm. The method was validated in the sample concentration range of 5.25 µg/mL for all the drugs, where it demonstrated good linearity with r = 0.9998, 0.9979, 0.9997, and 0.9987 (n = 6), respectively. For independent 100% level samples, the intra-day and inter-day precision was in the range i.e. < 2.0 for all the drugs. The method demonstrated robustness, resisting to small deliberate changes in pH, flow rate, and composition (organic:aqueous ratio) of the mobile phase. The limit of detection values were 0.071, 0.116, 0.134, and 0.110 µg/mL, while the limit of quantitation were 0.217, 0.352, 0.405, and 0.368 µg/mL for Metf, Cimt, Famt, and Rant, respectively. The applicability of the method was demonstrated by determining the drug content in pharmaceutical formulations, where it exhibited good performance.