Derivative spectrophotometric method for the determination of clarithromycin in pharmaceutical formulation and application to in-vitro dissolution

A simple spectrophotometric method has been developed and validated for quantitative determination of Clarithromycin (CLT) in pharmaceutical formulations. The method is based on derivatization of CLT with Bromotrimethylsilane (TMBS) and spectrophotometric estimation of CLT derivative at 268 nm using double beam spectrophotometer and quartz cells of 1 cm path length. Bear law obeyed over a concentration range of 5.0 to 60 μg mL-1 with specific absorbance (A=1%) of Clarithromycin derivative was 62.4 ± 0.2.0. The method was validated appropriately for accuracy, precision, linearity and specificity, according to the requirements of United State Pharmacopeia and International Conference on Harmonization guidelines for validation of analytical method (category I). The overall recovery of CLT was 100% ± 1% and RSD for precision and intra-day precision was less than 2.0%. The calibration curves were linear with correlation coefficient (R2>0.9998) and there was no interference of placebo of clarithromycin dosage form. The method was successfully used for determination of CLT in dosage form and in vitro dissolution studies.