Mahesh Nasare

A simple, rapid and specific Second order derivative spectroscopic method with good sensitivity was developed and validated for the simultaneous determination of Desloratidine and Pseudoephedrine HCl in pharmaceutical dosage form. In Ethanol, the quantitative determination of both drugs carried out using second derivatives values measured at 268 and 271 nm for Desloratidine and Pseudoephedrine HCl respectively using a Shimadzu UV-Visible spectrophotometer. In this proposed method both drugs obeyed linearity within the concentration range of 5-30 µg/ml and 80-800 µg/ml for Desloratidine and Pseudoephedrine HCl respectively. The low RSD values indicate good precision and high recovery values indicate accuracy of the proposed method. The proposed method has been applied to the determination of drugs in commercial formulations. Assay results were in good agreement with label claim. The method was validated as per ICH guidelines. The developed method was simple, accurate, precise, specific, sensitive and reproducible which can be efficiently and easily applied to pharmaceutical dosage forms.

A simple, precise, accurate and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method is developed for estimation of Isosorbide 5-Mononitrate in bulk drug and tablet dosage form. The method employed, with reverse phase phenomenex® Luna 5µ C18 (2) 100A (250 × 4.60 mm) column in an isocratic mode, with mobile phase of methanol: water: acetonitrile in the ratio 55:28:17 (%v/v/v). The flow rate was 1.0 ml/min and effluent was monitored at 217 nm. Retention time was found to be 4.391±0.015 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 1- 9 µg/ml respectively. The LOD and LOQ values for were found to be 2.5 and 10 ng/ml respectively. No chromatographic interference from tablet excipients and degradants were found. The proposed method was successfully used for estimation of Isosorbide 5-Mononitrate in tablet dosage form.

A rapid, simple, sensitive, accurate, and precise UV spectrophotometric method has been developed for the simultaneous estimation of anti-retroviral agents lamivudine, didanosine and efavirenz in pharmaceutical dosage form. The absorption maxima of the drugs were found to be 271, 250 and 247 nm for lamivudine, didanosine and efavirenz respectively. Lamivudine, didanosine and efavirenz obeyed Beer’s law in the concentration range of 10-100 µg/ml, 10-100 µg/ml and 10-70 µg/ml respectively. The percentage recovery was within the range of 98% - 101%, indicating that insignificant interference from the other ingredients in the formulation. The above method was validated in terms of linearity, accuracy, precision, Limit of Detection (LOD), Limit of Quantification (LOQ) etc. in accordance with ICH guide lines. The developed method was free from interferences due to excipients present in tablets. The method was rapid, simple and suitable for routine quality control analysis.

A simple, rapid and specific UV spectrophotometric method with good sensitivity was developed and validated for the simultaneous determination of tamsulosin and finasteride in bulk and pharmaceutical formulations. In methanol, the lambda max of finasteride and tamsulosin was fixed as 235 and 225nm respectively, using a Shimadzu UV–Visible spectrophotometer (model UV-1800) with quartz cells. In this proposed method both these drugs obeyed linearity individually and in mixture within the concentration range of 1- 10 μg ml-1 for tamsulosin and 12.5 - 100 μg ml-1 for finasteride, with a correlation coefficient value of  0.9992 and 0.9994 for tamsulosin and finasteride respectively. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed method. The proposed method had been applied to the determination of drugs in commercial formulations. Assay results were in good agreement with label claim. The method was validated according to the ICH guidelines.