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Simultaneous determination of two antispasmodic drugs in bulk, pharmaceutical products and body fluid by a validated, acetonitrile free, cost effective and stability indicating reverse phase high performance liquid chromatographic method

Najmul Hasan, Nawab Sher Afridi, Sauleha Khan, Muhammad Zain Siddiqui, Mathurot Chaiharn

A stability indicating, accurate, specific, precise, and simple reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of Phloroglucinol (PGD) and Trimethylphloroglucinol (TMP) in bulk, pharmaceutical dosage forms of tablet and in body fluid. Methanol: Buffer: Sulfuric Acid 0.1mol/l (60:40:0.3) was the mobile phase at flow rate 1.0 ml/min using a Symmetry C18 column monitored at 234nm. The APIÂ’s were subjected to stress conditions of hydrolysis (acid, base, oxidation, and thermal degradation). Maximum degradation was observed in acid and 35% H2O2 while found stable in the other stress conditions. The calibration curve was linear with a correlation coefficient of more than 0.9995 for both drugs. The averages of the absolute and relative recoveries were found to be 100.154% and 99.993% for Phloroglucinol and Trimethylphloroglucinol respectively, with 30pg/ml LOD and with 300pg/ml LOQ. The developed method was validated with respect to linearity, accuracy, precision, system suitability, specificity and robustness. The forced degradation studies prove the stability indicating power of the method. The proposed HPLC method was successfully applied to quantify the amount of Trimethylphloroglucinol and Phloroglucinol in bulk, dosage form and body fluid in quality control.