Abstract

VALIDATED UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF FIXED DOSE COMBINATION OF CIPROFLOXACIN, TINIDAZOLE AND DICYCLOMINE IN BULK AND TABLET FORMULATION

Malathi Raghunath, Amol Dhamne, Vaishali Mistry and Vaidhun Bhaskar

ABSTRACT

The aim of the present study was to develop a simple, accurate, precise, reproducible and economical UV spectrophotometric method for estimation of Ciprofloxacin hydrochloride (CPX), Tinidazole (TNZ) and Dicyclomine hydrochloride (DIC) in bulk and tablet formulation. The method of absorbance corrected for interference was used for quantitative estimation of DIC where as absorbance ratio method was used for simultaneous estimation of CPX & TNZ. The UV absorbance was determined at 274 nm (λmax of CPX), 340nm (isobestic point of CPX and TNZ) and 218 nm (λmax of DIC) respectively. A solvent system of methanol: 0.1N NaOH (3:2) was used to dissolve the drugs. CPX and TNZ showed linearity at all the selected wavelengths, where as DIC showed zero absorbance at λmax of CPX and TNZ. The solutions of CPX, TNZ and DIC obeyed Beer’s law in the concentration range of 2-10 μg/ml, 2-20 μg/ml and 100-500 μg/ml respectively. The method was validated for parameters such as linearity, accuracy, precision, and limit of quantification, limit of detection, ruggedness and robustness as per ICH guidelines. The proposed method is thus recommended for routine analysis of fixed dose combination of these drugs in bulk and tablet formulations without any interference of the excipients.

Keywords: Ciprofloxacin, Tinidazole, Dicyclomine, Validation, Absorbance corrected for interference method, Absorbance ratio method.