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Reddy Alavala, Rajasekhar
- Acute, Sub-Acute and Genotoxicity Assessment of Cocculus hirsutus Hydroalcoholic Leaf Extract in Wistar Rats
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Authors
Uma Sankar Gorla
1,
G. S. N. Koteswara Rao
1,
Umasankar Kulandaivelu
1,
Rajasekhar Reddy Alavala
2,
Siva Prasad Panda
2,
Rajkiran Kolakota
3
Affiliations
1 College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram – 522502, Andhra Pradesh, IN
2 College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram – 522502, Andhra Pradesh., IN
3 2Vignan Institute of Pharmaceutical Technology, Duvvada, Visakhapatnam – 534202, Andhra Pradesh, IN
1 College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram – 522502, Andhra Pradesh, IN
2 College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram – 522502, Andhra Pradesh., IN
3 2Vignan Institute of Pharmaceutical Technology, Duvvada, Visakhapatnam – 534202, Andhra Pradesh, IN
Source
Toxicology International (Formerly Indian Journal of Toxicology), Vol 28, No 2 (2021), Pagination: 177-186Abstract
Acute (0, 500, 1000 and 2000 mg/kg) and 28-day (0, 100, 200 and 400 mg/kg) toxicity assessments of Csocculu hirsutus hydroalcoholic leaf extract (CH-Ex) were performed in Wistar rats consistent with OECD guidelines 423 and 407 respectively. Average body weights were recorded, blood and biochemical parameters were analyzed and histopathological studies were performed. At doses (12.5–100 μg/ml), genotoxicity assessments were conducted on pUC 19 plasmid by evaluating DNA damage protection. Acute toxicity assessment categorized CH-Ex as safe and non-toxic (category 5). The 28-day toxicity assessments showed no significant (p>0.05) changes in body weights, hematology and histopathology. At 400 mg/kg females exhibited a slight decline in SGPT, creatinine and BUN levels, while male rats exhibited a slight enhancement of SGOT and ALP levels (p<0.05). CH-Ex exhibited strong ability to protect DNA damage from oxidative stress in a dose-dependent manner.Keywords
Biochemical, Cocculus hirsutus, DNA Damage, Histopathological, Oxidative Stress, ToxicityReferences
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- 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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