Spectroscopic and HPLC methods for the determination of alendronate in tablets and urine

Two methods (spectrophotometric and HPLC) have been developed and validated for the analysis of alendronate sodium in tablet dosage form. Both methods depend on the ability of alendronate sodium to react with o-phthalaidehyde (OPA) at basic pH to produce a light-absorbing derivative. The derivative was found to possess absorption maximum at 330 nm where neither the derivatizing agent nor the analyte had any absorption. Thus, spectroscopic method was based on the derivatization-induced absorption of alendronate sodium at 333 nm. The HPLC method was based on separation of the formed derivative from other ingredients in tablets with detection at 333 nm. Both methods were satisfactory with regard to accuracy, prescion and linearity. Moreover, a HPLC method with fluorescence detection (HPLC-FD) was developed for the quantification of alendronate sodium in urine. The method was also based on the derivatization of alendronate with OPA, but fluorescence detection was employed. Linearity, recovery, selectivity, prescision and sensitivity were satisfactory for the proposed HPLC-FD method. Yet a new quantification limit (0.6 ng ml(-1)) for alendronate in urine was achieved. (C) 2004 Elsevier B.V. All rights reserved.