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Koteswara Rao, GSN
- Development and Validation of a Stability Indicating Uplc Method for Determination of Darolutamide in Its Tablet Formulation
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Authors
Poojari Venkatesh
1,
Umasankar Kulandaivelu
1,
GSN Koteswara Rao
1,
Guntupalli Chakravarthi
1,
Rajasekhar Reddy Alavala
1,
Bandlamuri Rajesh
1
Affiliations
1 K L College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram, Guntur, Andhra Pradesh,, IN
1 K L College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram, Guntur, Andhra Pradesh,, IN
Source
Research Journal of Pharmacy and Technology, Vol 15, No 1 (2022), Pagination: 165-170Abstract
Darolutamide is an orally active, second generation non-steroidal anti-androgen. The objective of this study was to develop a simple and fast stability indicating method for the determination of Darolutamide in bulk and tablets. Darolutamide was eluted on a Zorbax SB-C18 column (100X2.1mmX1.8μ) with a mobile phase of 8mM ammonium acetate, pH: 5.4: acetonitrile (66:34 v / v) in isocratic mode at a flow rate of 0.4 ml / min. The analyte was quantified using a 272 nm PDA detector. The chromatograms of darolutamide obtained with this method showed a well resolved retention time at 0.83 min of its excipients and degradation products. The area of the peak with respect to the concentration calibration curves, which were linear from 70 to 210 μg / ml, had a regression coefficient (r2) greater than 0.999. The detection limit (LOD) and the limit of quantification (LOQ) were found at 1.80 and 6.01 μg/mL respectively. Accuracy and precision have been determined and perfectly matched to the ICH standards. The study showed that the proposed UPLC method was simple, fast, robust and reproducible, which can be used for the evaluation of the purity and stability of the drug without interference from excipients or decomposition products of active pharmaceutical ingredients.Keywords
Darolutamid, non-steroidal anti-androgen, Zorbax, ammonium acetate, acetonitrile.References
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- Influence of Eugenol on the Pharmacokinetics and Pharmacodynamics Of Gliclazide in Rabbits
Abstract Views :83 |
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Authors
Roja Rani Budha
1,
Santhrani Thaakur
1,
GSN Koteswara Rao
2,
Lavanya Yaidikar
3,
M. Sathish Kumar
4,
Ravi Manne
5
Affiliations
1 Institute of Pharmaceutical Technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupati, A.P., 517502,, IN
2 Department of Pharmacy, School of Medical and Allied Sciences, Galgotias University, Greater Noida, U.P. 203201., IN
3 Department of Pharmacology, Seven Hills College of Pharmacy, Tirupati, A.P., 517561,, IN
4 Department of Pharmacology, Bapatla College of Pharmacy, Bapatla, A.P., 522101,, IN
5 Department of QA & QC, Chemtex Inc., Texas, 77642,, US
1 Institute of Pharmaceutical Technology, Sri Padmavathi Mahila Visvavidyalayam, Tirupati, A.P., 517502,, IN
2 Department of Pharmacy, School of Medical and Allied Sciences, Galgotias University, Greater Noida, U.P. 203201., IN
3 Department of Pharmacology, Seven Hills College of Pharmacy, Tirupati, A.P., 517561,, IN
4 Department of Pharmacology, Bapatla College of Pharmacy, Bapatla, A.P., 522101,, IN
5 Department of QA & QC, Chemtex Inc., Texas, 77642,, US
Source
Research Journal of Pharmacy and Technology, Vol 15, No 2 (2022), Pagination: 787-791Abstract
Diabetes is the most prevailing health disorder with high mortality rate and showing increased health costs across the globe. World Health Organization has claimed that lifestyle changes are one of the major causes of diabetes in this modern living. Gliclazide is an oral antidiabetic drug that is taken by majority of patients suffering with type-2 diabetes. With the increased awareness of nutraceuticals in health care management, many patients are consuming them. Hence, in the present investigation it is sought to determine the pharmacokinetic and pharmacodynamic interactions of gliclazide with eugenol in diabetic induced rabbits. Streptozotocin was used for inducing diabetes in healthy rabbits. Four different groups, each with 6 rabbits, are taken in the study. Group A is diabetic control, Group B is treated with gliclazide alone, Group C is treated with eugenol alone and Group D is treated with combination of gliclazide and eugenol. The results clearly indicated that there is an advantage in both pharmacokinetic and pharmacodynamic parameters with combination therapy of gliclazide and eugenol in diabetic rabbits.Keywords
Gliclazide, Eugenol, Rabbits, Pharmacokinetics, Pharmacodynamics, Interactions.References
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