Article Per Year (5 Year)
p-Index From 2021 - 2026
0.444
P-Index
This Author published in this journals
All Journal Journal of Applied Pharmaceutical Research
Talole, Shubham
Unknown Affiliation
Medicine & Pharmacology

Published : 2 Documents Claim Missing Document
Claim Missing Document
Check
Articles

Found 2 Documents
Search

 1 
Development and validation of a QbD-based RP-HPLC method for vericiguat quantification Mandhare, Shubham; Godge, Rahul; Vikhe, Akshay; Talole, Shubham
Journal of Applied Pharmaceutical Research Vol. 12 No. 2 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.18231/j.joapr.2024.12.2.57.67

Abstract

Aim: An RP-HPLC method for Vericiguat using the QbD approach was developed and validated by ICH guidelines. Method: The ICH (Q2R1) guidelines have been followed in the development and validation of an RP-HPLC technique by considering several validation parameters like linearity, precision, LOD, LOQ, and accuracy. The study was performed on Agilent Tech using the C18 column (4.6x250 mm; 5 µm) and Chemstation 10.1 software with statistical data analysis, and the detector used was UV (DAD). Results: The mobile phase used for separation was Methanol: 0.1% OPA in the ratio of (76:24) at room temperature, the flow rate was 0.8ml/min, and the wavelength was 331nm. The results indicated that the quantification limit was 0.7209 µg/ml, and the detection limit was 0.2379 µg/ml. Conclusion: The validation studies confirmed that the developed method is fast, accurate, precise, cost-effective, selective, and useful for routine analysis of vericiguat in tablet dosage forms.
Formulation and optimization of upadacitinib-loaded transdermal patches for rheumatoid arthritis with zero-order release kinetics Talole, Shubham; Godge, Rahul; Tambe, Nikita; Mhase, Nikita
Journal of Applied Pharmaceutical Research Vol. 13 No. 2 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i2.1037

Abstract

Background: To develop and optimize Upadacitinib-loaded transdermal patches for rheumatoid arthritis treatment with improved patient compliance and sustained drug delivery. Methodology: Upadacitinib transdermal patches were formulated using a 3² factorial design approach with PVP K30 and HPMC K4M as key polymeric components. The patches were characterized for physicochemical, mechanical, and ex vivo permeation properties. Results and Discussion: The optimized formulation (SF8) exhibited excellent physicochemical characteristics, including high drug content (99.05 ± 0.83%), optimal mechanical properties with tensile strength of 0.912 kg/mm² and adhesion strength of 3.94 N. The ex vivo permeation reached 86.35% at 12h, with the flux of 102.91 μg/cm²/h following zero-order kinetics (R² = 0.9777). The experimental values closely matched predicted values with less than 2% error. Accelerated stability studies confirmed minimal changes in critical parameters over six months. Conclusion: The optimized Upadacitinib transdermal patch provides sustained drug delivery with zero-order release kinetics and excellent stability. This transdermal delivery system offers a promising alternative to oral therapy with potential advantages of improved patient compliance, reduced dosing frequency, and avoidance of first-pass metabolism for rheumatoid arthritis management
Co-Authors Godge, Rahul Mandhare, Shubham Mhase, Nikita Tambe, Nikita Vikhe, Akshay