Development & Validation of UV Spectrophotome...

Development & Validation of UV Spectrophotometric Method for Simultaneous Estimation of Cilnidipine & Fimasartan In Synthetic Mixture

Author Name : Suraj Singh, Mohammed Azhar Khan, Neel Rathod, Dhruv Parmar, Dhaval Rathva, Prof. Mitali Dalwadi, Prof. Khyati Patel, Dr. Umesh Upadhyay

ABSTRACT

It is very important to have simple but fast procedures to determine the active ingredient concentrations in drug substances as the significant deviation from labelled amount might negatively affect the patients. The objective of this research is to describe the optimization, validation, and application of spectrophotometric techniques for determination of Cilnidipine and Fimasartan in their pharmaceutical formulation (tablets). The method has been developed according to the International Conference on Harmonization (ICH) guidelines and validated using the acceptance methods have been developed and validated. This method is a direct spectrophotometric method depends on dissolve of Cilnidipine and Fimasartan in diluted methanol. The method is based on measurement of absorbance of Cilnidipine and Fimasartan at their respective wavelength of 240nm and 262nm.The maximum absorption wavelength for determination of CIL & FMS drug was found to be at 240 nm and 262 nm. for Beer's law was obeyed in the concentration range from 2 to 10 µg/ml for UV. The regression Co-efficient value of Cilnidipine and Fimasartan Synthetic Mixture was found to be y = 0.041x + 0.1351 and y= 0.0337x+0.3484 respectively for both the drug and correlation coefficient was found to be 0.9998  and 0.9997 criteria of linearity, range, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), and stability. In this paper simple, rapid, accurate and sensitive spectrophotometric

Key words: UV Spectrophotometry, Wavelength, Cilnidipine, Fimasartan, Synthetic Mixture., Validation ,Accuracy, LOD, LOQ, Precision, Range.