Development and Validation of RP–HPLC Method for the Estimation of Balsalazide in Pure and in Pharmaceutical Dosage forms

A simple, precise, rapid and accurate RP-HPLC method was developed and validated for the estimation of Balsalazide in bulk and in capsule dosage forms. Isocratic elution at a flow rate of 0.7 ml/min was employed on a Phenomenax Luna C18 column (150×4.6mm; 5μ) at an ambient temperature. The mobile phase consists of Acetonitrile: Methanol: Triethylamine buffer (40:30:30% v/v). The effluents were monitored at 254nm and 20μl of sample was injected. Nifedipine was used as an internal standard (IS). The retention times for Balsalazide and IS were 3.42 and 5.07 min, respectively. The method obeys Beer's law in the concentration range of 10–50 μg/ml. The respective linear regression equation being Y= 0.03727x + (−0.0084). The percentage assay of BSZ was 99.61% ± 0.106. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of BSZ in bulk drug and in its pharmaceutical dosage form.