DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DICYCLOMINE HYDROCHLORIDE AND FAMOTIDINE IN BULK AND TABLETS

In the present study an isocratic reverse phase-high performance liquid chromatography (RP-HPLC) method was developed and validated for simultaneous estimation of dicyclomine hydrochloride (DCY) and famotidine (FAM) in bulk and pharmaceutical dosage forms. The separation was achieved on a Phenomex Gemini C-18 column (4.6 x 250 mm, 5 mu particle size) using a mixture of methanol and 0.1% triethylamine (TEA) pH 3.0 (adjusted with orthophosphoric acid) in the ratio of 40: 60 (v/v) as a mobile phase. The flow rate was 1.0 mL min(-1), column temperature was kept at 28 degrees C and detection was monitored at 270 nm. The retention time of dicyclomine hydrochloride and famotidine was found to be 10.72 and 2.72 min respectively. Recovery studies were satisfactory and the correlation coefficient for FAM and DCY were 0.9947 and 0.9935 respectively, indicates linearity of the methods within the limits. The developed method can be used for routine quality control simultaneous analysis of DCY and FAM in tablet dosage form without any interference of excipients.