DEVELOPMENT OF SPECTROPHOTOMETRIC AND FLUOROMETRIC METHODS FOR ESTIMATION OF DARUNAVIR USING QBD APPROACH

Objective: The main objective of the present study is to develop newer simple, precise spectrophotometric and fluorometric methods of estimation for Darunavir using coupling agent O-pthaladehyde.Methods: The experimental work was designed for both spectroscopic and fluorometric method development and validation. The method is based on formation complex of Darunavir with O-pthaladehyde. QbD approach was applied by varying different parameters. These parameters were designed into Ishikawa diagram.Results: The complex Darunavir-Phthalaldehyde in methanol with 0.1 N HCl showed linearity for both spectrophotometric and fluorometric methods. The calibration curve by spectrophotometry is linear in concentration range of 2-22 µg/ml with regression coefficient (R2) = 0.998 at 355 nm and for fluorometry it is linear in concentration range of 0.5-5.0 ng/ml with regression coefficient (R2) = 0.999. This method was found to be rugged and robust in different testing criteria with % RSD less than 2. The limit of detection and limit of quantification was found to be 0.2 μg/ml and 0.8 μg/ml for a spectrophotometric method and 0.12 μg/ml and 0.43 μg/ml for fluorometric method respectively.Conclusion: Both methods were found to be precise with % RSD of less than 2. The % recovery of the spectrophotometric and fluorometric methods was found to be 101.04 %, 98.15 % respectively. In this way, the results of all validation parameter were within the limits as per International Conference on Harmonization guideline.Â

DEVELOPMENT OF NEWER CONDUCTOMETRIC METHOD FOR ESTIMATION OF TELMISARTAN IN PURE AND FORMULATION

Objective of the present study is to develop simple, easily accessible, economic, newer conductometric method of estimation for Telmisartan. Telmisartan is weak acid due to presence of acidic functional group which can be estimated by conductometric method in alcoholic media.  The developed method was validated according to ICH guidelines for parameters like accuracy, precision, specificity, ruggedness, robustness and percentage recovery. Results: The Relative Standard Deviation was 0.701677; recovery was 98-100%. Tablet formulations were used as sample for estimation and the results are found to be well within the specified limit. Conclusion: Therefore developed method can used for estimation of Telmisatan in pure or in formulations. Key words: Conductometry, Telmisartan, Estimation, Weak acid