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Baldi, Ashish
- Method Development and Validation for Estimation of Quetiapine Fumarate by RP-HPLC
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Authors
Affiliations
1 College of Pharmacy, Shri R.M.S. Institute of Science and Technology, Bhanpura-458775, Dist. Mandsaur, (M.P.), IN
1 College of Pharmacy, Shri R.M.S. Institute of Science and Technology, Bhanpura-458775, Dist. Mandsaur, (M.P.), IN
Source
Asian Journal of Research in Chemistry, Vol 3, No 3 (2010), Pagination: 604-607Abstract
A precise and accurate reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for estimation of quetiapine fumarate. The mobile phase consisted of methanol:water:acetonitrile (50:40:10) was used at a flow rate of 1 ml/min and pH value of 7.0, adjusted with orthophosphosphoric acid. The detection was carried out at a wavelength of 251 nm. The developed method was found to be in accordance with ICH guidelines with respect to accuracy, precision, reproducibility, linearity and specificity.Keywords
Quetiapine Fumarate, RP-HPLC, Validation.
- Intricacies in the Approval of Radiopharmaceuticals – Regulatory Perspectives and the Way Forward
Abstract Views :255 |
PDF Views:70
Authors
Affiliations
1 I. K. Gujral Punjab Technical University, Jalandhar - 144 603, IN
2 National Institute of Pharmaceutical Education and Research, SAS Nagar - 160 062, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda - 151 001, IN
4 Shivalik College of Pharmacy, Nangal, Rupnagar - 140 126, IN
5 Defence Food Research Laboratory, Siddartha Nagar, Mysuru - 570 011, IN
1 I. K. Gujral Punjab Technical University, Jalandhar - 144 603, IN
2 National Institute of Pharmaceutical Education and Research, SAS Nagar - 160 062, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda - 151 001, IN
4 Shivalik College of Pharmacy, Nangal, Rupnagar - 140 126, IN
5 Defence Food Research Laboratory, Siddartha Nagar, Mysuru - 570 011, IN
Source
Current Science, Vol 116, No 1 (2019), Pagination: 47-55Abstract
Extensive research by the global scientific fraternity has led to the production of many radiopharmaceuticals of immense clinical importance. However, this increasing availability has not been matched by adequate regulatory action to back up the legal foundation for their commercial use. It is imperative for a radiopharmaceutical to have a seal of regulatory authority approval to qualify for human use. The present article highlights various regulatory requirements for approval of radio-pharmaceuticals in USA, Europe, and particularly India, which does not have guidelines for their approval, and intensifies the concern for a harmonized regulatory platform of global acceptance.Keywords
Approval, Commercial Use, Guidelines, Radiopharmaceuticals, Regulatory Authority.Full Text
References
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- The Regulatory Dilemma for Import of Radiopharmaceuticals in India
Abstract Views :255 |
PDF Views:74
Authors
Affiliations
1 I.K. Gujral Punjab Technical University, Jalandhar 144 603, IN
2 Raja Ramanna Fellow, BARC, Radiation Medicine Centre and BRIT, Mumbai 400 012, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda 151 001, IN
4 Shivalik College of Pharmacy, Nangal, District Rupnagar 140 126,, IN
5 Saveetha Institute of Medical and Technical Sciences, Chennai 602 105, IN
1 I.K. Gujral Punjab Technical University, Jalandhar 144 603, IN
2 Raja Ramanna Fellow, BARC, Radiation Medicine Centre and BRIT, Mumbai 400 012, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda 151 001, IN
4 Shivalik College of Pharmacy, Nangal, District Rupnagar 140 126,, IN
5 Saveetha Institute of Medical and Technical Sciences, Chennai 602 105, IN
Source
Current Science, Vol 116, No 11 (2019), Pagination: 1787-1789Abstract
The inclusion of monographs of several radiopharmaceuticals in the Indian Pharmacopoeia has drawn the attention of drug control authorities in the country and other stakeholders. Therefore, in a move towards better regulation of radiopharmaceuticals, the Office of the Drug Controller General of India has issued some important notices concerning their import. However, these notices have resulted in several misgivings among the nuclear medicine community as appointment of patients for nuclear medicine scans had to be cancelled/rescheduled and clinical decisions delayed. An analysis of the sequence of events is presented in this study, highlighting the effects of decisions taken regarding import of radiopharmaceuticals, and suggestions to implement regulations with minimal repercussions.Full Text
References
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