Development and Validation of Spectrophotome...

Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Cefiximeand Ornidazole as API and in Fixed Dose Combination

Author Name : Vishal Chudasama, Megha Patel, Kiran Suthar, Bharat Rajpurohit, Ashok Patel

ABSTRACT Two simple, precise, rapid and economic spectrophotometric methods have been developed for simultaneous determination of Cefixime and Ornidazole in bulk powder and combined dosage form. Method (I) is based on simultaneous equation method while Method (II) depends on UV-spectrophotometric determination using Qabsorbance ratio method.Simultaneous equation method is based on formation of Simultaneous equations at two wavelengths, which are λ-max of both.Q-Absorbance ratio method is based on formation of Q- absorbance equations at two wavelengths, one is an Isoabsorptive point and another is the λ-max of one of the two drugs. Absorbances are measured at three selected wavelengths;1. 287.4 nm [λ-max of Cefixime], 2. 318.6 nm [λ-max of Ornidazole] and 3. 303.8 nm [Isoabsorptive point]. The two drugs comply with Beer’s lambert's law over the linearity range of 1-25 μg/ml for both mrthods. The methods were validated as per International Conference on Harmonization (ICH) guidelines in terms of linearity, accuracy (recovery study), precision (repeatability, intraday, inter-day precision), limit of detection and limit of quantification, Specificity and robustness. All the validation parameters were found to be within acceptable limits. The methods were found to be suitable for theroutine analysis of both the drugs in pharmaceutical dosage form.