Abstract
DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND TELMISARTAN IN BULK DRUGS AND PHARMACEUTICAL DOSAGE FORM

Paresh G. Chaudhari*1, Minal Y. Chaudhari2, Prof. Sachin S. Rane, Prof. (Dr.) Rajesh Y. Chaudhari,
Prof. (Dr.) Vijay R. Patil

ABSTRACT

A simple, robust, precise, UV spectroscopic method has been developed for the simultaneous estimation of CIL and TEL in bulk and tablet dosage forms. In this paper the estimation of those drugs was carried out by simultaneous equation method. Literature survey revealed that cilnidipine can be estimated by spectrophotometry and by liquid chromatographic methods individually or incombination with other drugs, and telmisartan can be estimated by spectrophotometry. This method is based on measurement of absorption at 243nm and 295nm i.e, λmax of CIL and TEL respectively. The linearity observed for Cil is in the range of 2-10 μg/ml and for Tel is in the range of 8-40 μg/ml. The accuracy of methods was assessed by recovery studies and was found to be within the range of 99.5%-100.5% for both CIL and TEL. The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The method can be employed for estimation of pharmaceutical formulations with no interference from any other excipients and diluents. The results were validated as per ICH guidelines. Cilnidipine and telmisartan in their combined dosage form. Dual wavelength spectrophotometric method is considered to be a good alternative, and it should be widely explored as an important tool in routine drug analysis. In both the methods linearity for detector response was observed in the concentration range of 2-10μg/ml (for CIL) and8-40μg/ml (for TEL). In both the methods linearity for detector response was observed in the concentration range of 2-10μg/ml (for CIL) and 8-40μg/ml (for TEL). In both the methods linearity for detector response was observed in the concentration range of 2-10μg/ml (for CIL) and 8-40μg/ml (for TEL). Absorptivity coefficient were calculated for both the drugs at selected wavelengths and substituted in equations for determining concentration of CIL and TEL in its tablet dosage form. This method is very useful for quality control analysis of CIL and TEL in various pharmaceutical laboratories.

Keywords: Cilnidipine, Telmisartan, ICH, Simultaneous estimation, absorbance ratio, Validation.


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