Shivani Jani - Academia.edu (original) (raw)
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Papers by Shivani Jani
International Journal of Pharmaceutical Chemistry and Analysis
Current research paper describes highly specific and reproducible 1 order derivative spectroscopi... more Current research paper describes highly specific and reproducible 1 order derivative spectroscopic method for quantitative analysis of Sitagliptin which is a DPP4 inhibitors and Dapagliflozin which is SGLT2 inhibitors from its synthetic mixture. Both drugs are from Anti Diabetics class. Present analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methyl alcohol as solvent. Quantification of Sitagliptin was carried out at zero cross over point of Dapagliflozin that is 275 nm and for Dapagliflozin, it was achieved at 232 nm which is zero cross over point of Sitagliptin. Method shows linear response in the range of 25-125 µg/mL of Sitagliptin and 2.5-12.5 µg/mL of Dapagliflozin. Method was found to be accurate with recovery between 99.3 – 100.1 % for Sitagliptin and 98.2 – 100.7 % for Dapagliflozin. The developed method was validated as per ICH Q2 R1 guidelines and was successfully applied for quantitative analysis of s...
Applied Clinical Research, Clinical Trials and Regulatory Affairs
Background: Literature review suggested that regulatory guidelines should be harmonized for bette... more Background: Literature review suggested that regulatory guidelines should be harmonized for better processing of applications and for the upliftment of the regulatory field. Therefore it was thought worthwhile to compare the guidelines for countries where there is requirement of harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries and still they are not a part of EU. Introduction: Kosovo, Ukraine and Serbia are small countries of Europe but they are not members of European Union. They have their own guidelines for the submission of MAA for marketing of pharmaceuticals and medical devices. They are trying to obtain the EU membership and therefore it was worthwhile to compare the guidelines of these countries. Method: The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied throughly. Along with it, the guidelines for European Union were also studied. A comparison of guidelines of all the three countries with the guid...
International Journal of Pharmaceutical Chemistry and Analysis
Current research paper describes highly specific and reproducible 1 order derivative spectroscopi... more Current research paper describes highly specific and reproducible 1 order derivative spectroscopic method for quantitative analysis of Sitagliptin which is a DPP4 inhibitors and Dapagliflozin which is SGLT2 inhibitors from its synthetic mixture. Both drugs are from Anti Diabetics class. Present analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methyl alcohol as solvent. Quantification of Sitagliptin was carried out at zero cross over point of Dapagliflozin that is 275 nm and for Dapagliflozin, it was achieved at 232 nm which is zero cross over point of Sitagliptin. Method shows linear response in the range of 25-125 µg/mL of Sitagliptin and 2.5-12.5 µg/mL of Dapagliflozin. Method was found to be accurate with recovery between 99.3 – 100.1 % for Sitagliptin and 98.2 – 100.7 % for Dapagliflozin. The developed method was validated as per ICH Q2 R1 guidelines and was successfully applied for quantitative analysis of s...
Applied Clinical Research, Clinical Trials and Regulatory Affairs
Background: Literature review suggested that regulatory guidelines should be harmonized for bette... more Background: Literature review suggested that regulatory guidelines should be harmonized for better processing of applications and for the upliftment of the regulatory field. Therefore it was thought worthwhile to compare the guidelines for countries where there is requirement of harmonization. Kosovo, Ukraine and Serbia were selected because of being European countries and still they are not a part of EU. Introduction: Kosovo, Ukraine and Serbia are small countries of Europe but they are not members of European Union. They have their own guidelines for the submission of MAA for marketing of pharmaceuticals and medical devices. They are trying to obtain the EU membership and therefore it was worthwhile to compare the guidelines of these countries. Method: The registration process of pharmaceuticals in Kosovo, Ukraine and Serbia was studied throughly. Along with it, the guidelines for European Union were also studied. A comparison of guidelines of all the three countries with the guid...