Tamizh Mani

  A new, simple, economic and sensitive UV-spectrophotometric method was developed for the determination of Sorafenib in bulk and pharmaceutical formulations. The developed spectrometric method was validated for selectivity, linearity, range, precision, accuracy, ruggedness and sensitivity. The method has demonstrated excellent linearity over the range of 2-10 μg/ml with regression equation: y=0.079x-0.0081 and regression correlation coefficient r2=0.999. The developed method demonstrated consistent high recoveries (97–99%) and low relative standard deviation (< 5%) at 265 nm. Moreover, the method was found to be highly sensitive with low limit of detection (0.028 μg/ml) and limit of quantitation (0.085 μg/ml). The apparent molar absorptivity and Sandell's sensitivity was found to be 48.09 mol-1cm-1 and 0.013245 µg/cm2, respectively. The validated method was successfully employed for the drug content analysis from tablet preparations. Additionally, the method was also employed for pH metric solubility analysis of the drug.

  A simple, specific, accurate and precise First order derivative UV Spectrophptometry method was developed and validated for the estimation of Efavirenz in bulk and pharmaceutical dosage forms. The stock solution was prepared by weighing 100 mg of standard EFV in 100 ml volumetric flask with methanol and water (50:50) (Stock solution I). The final stock solution was made to produce 100µg/ml with methanol and water (50:50).Further dilutions were prepared as per procedure. The first derivative amplitude at 238.50 nm was selected for the assay. The linearity was found in the concentration range of 3-18 µg/ml. The Correlation coefficient was 0.999. The regression equation was found to be y = 0.038 x - 0.001. The method was validated for linearity, sensitivity, precision, accuracy and ruggedness. The limit of detection and limit of quantification for estimation of EFV was found to be 0.078µg/ml and 0.236 µg/ml, respectively. Recovery of EFV was found to be in the range of 99.08-99.97 %. Proposed method was successfully applied for the quantitative determination of EFV in bulk and pharmaceutical dosage forms. These methods were tested and validated for various parameters according to ICH guidelines. The proposed methods were successfully applied for the determination of EFV in capsule formulations. This method was successfully applied to the pharmaceutical dosage form and there no interference of capsule excipients was found in recovery study. Key words: Efavirenz (EFV), ICH (International Conference on Harmonization), and UV- Spectrophotometric method.

  In the present research a simple, accurate, precise and cost effective UV-Vis spectrophotometric method for the estimation of Clobazam, in bulk and pharmaceutical dosage form was illustrated. The absorption maxima of the drug was found to be 230 nm in methanol: water (1:1). A linear response was observed in the range of 6- 16 µg/ml with a regression coefficient of 0.999. Validation parameters were carried out as per the guidelines of International Conference for Harmonization. This method can be used in the industries for determination of Clobazam to analyze the quality of formulation without interference of the excipients.   Key words: Clobazam, Anti-epileptic, λmax, ICH, UV-Vis spectroscopy.