DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR THE DETERMINATION OF PINDOLOL AND CLOPAMIDE IN TABLETS

Abstract

A high-performance liquid chromatographic method was developed for the simultaneous determination of pindolol and clopamide in pharmaceutical dosage forms. The use of a β-cyclodextrin bonded-phase column results in satisfactory separation of both of the compounds. The mobile phase consisted of a mixture of 1.0% w/v triethylamine acetate buffer (pH = 5.5) and methanol (90:10, v/v), pumped at a flow rate 0.8 mL/min. The UV detector was operated at 245 nm. Calibration graphs are linear (r better than 0.99997, n = 5), in concentration range 1.0–3.0 μg/mL for pindolol and 0.5–1.5 mg/mL for clopamide. The intra- and interday R.S.D. values were less than 2.97% (n = 5), while the relative percentage error Er was less than 2.0% (n = 5). Detection limits were 0.12 and 0.16 mg/mL for pindolol and clopamide, respectively. The method was applied in the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.