Abstract
A simple and accurate ion-pair reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for determination of acebutolol (ACE) in tablet dosage forms. Both ACE and ambroxol (internal standard) were well separated using a reversed phase column and a mobile phase consisting of a mixture of methanol-0.05 M acetic acid (containing 8 mM sodium 1-heptanesulfanate) (65:35 v/v) with pH adjusted to 3.2 with triethylamine. The mobile phase was pumped at 0.80 mL min−1 flow rate and ACE was detected by diode-array detection at 240 nm. The retention times for ACE and internal standard (IS) were 4.574 and 8.236 min, respectively. A linear response (r = 0.9998) was observed in the range of 0.27–2.93 μg mL−1 in mobile phase. The limit of detection and limit of quantification were found as 0.07 and 0.23 μg mL−1 in the mobile phase. Validation parameters such as precision, accuracy, selectivity, reproducibility, and system suitability tests were also determined. The excipients did not interfere with the assay of ACE in tablet dosage forms. It is suggested that the proposed method can be used for routine quality control and dosage-form assay of ACE.
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