Validation Study of the HPLC Assay of Some Antiamoebic Agents

Author(s): N. D. Dinesh and K. S. Rangappa

A simple reversed phase HPLC method has been developed for the assay of tinidazole (TZ) and metronidazole (MZ) in their pure form and in formulations. Methanol, water and acetic acid in the ratio 65 : 33 : 2 was used as mobile phase with flow rate of 1 mL per min. LiChrospher C18-5 μm (25 x 0.46 cm) column was used and UV detection was made at 268 nm. The internal standard method using sparfloxacin (SP) as the internal standard is used. The linear dynamic range was found to be 0.08 - 9.5 μg mL1 and 0.07 - 8.5 μg mL-1 for metronidazole and tinidazole, respectively. The proposed method is successively employed for the determination of these drugs in tablets and injections. The excipients present in the formulations did not interfere with the assay procedure. Proposed method was found to be simple, sensitive, reproducible, rugged and accurate. Analytical parameters were calculated and full statistical evaluation is included

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