Development and validation of spectrophotometric method for the determination of cyclophosphamide in bulk drug and its pharmaceutical dosage form

Abstract

Objective: To develop a simple, sensitive and reproducible spectrophotometric method for the determination of Cyclophosphamide (CP) in bulk and pharmaceutical formulations. Method: The proposed method is based on the formation of a blue colored complex of the drug with ammonium molybdate, which is measured spectrophotometrically at 722 nm. The color was stable for an hour. Reasults: Beer's law is obeyed over a concentration range from 20-45?g/ml. The apparent molar absorptivity and Sandell sensitivity values are 0.90948×104L mol-1cm-1 and 0.02870?g/cm-2 respectively. The LOD and LOQ of the proposed method were calculated 0.02559 and 0.08521?g/ml respectively. All the variables were studied to optimize the reaction conditions. No interference was observed in the presence of common pharmaceutical excipients. The validity of the method was tested by analyzing CP in its pharmaceutical formulations and critically tested for its accuracy by statistical tests. Conclusion: Good recoveries were obtained by the developed method; the obtained results were critically analyzed and successfully employed for the determination of CP in its pharmaceutical dosage forms.