MUMBAI, India, Sept. 28 -- Intellectual Property India has published a patent application (202641112554 A) filed by Sandip Sen; Dr R. Vani; Dr. Ayesha Begum K; Dr. Tandrima Majumder; Dr. Md Samsheer Alam; Karuna Pandey; Allakonda Rajamani; Jagadeeshwar K; Ms. G. Surekha; and Ms. Anandi Kapri on September 19, 2026, for A Novel Ultra-Performance Liquid Chromatographic Method For The Quantitative Determination Of Zalcitabine In Bulk Drug And Pharmaceutical Dosage Forms.
Inventors include Sandip Sen; Dr R. Vani; Dr. Ayesha Begum K; Dr. Tandrima Majumder; Dr. Md Samsheer Alam; Karuna Pandey; Allakonda Rajamani; Jagadeeshwar K; Ms. G. Surekha; and Ms. Anandi Kapri.
The application for the patent was published on September 25, 2026, under issue no. 39/2026.
Abstract: The present invention relates to a rapid and stability-indicating Ultra-Performance Liquid Chromatographic (UPLC) method for quantitative determination of zalcitabine in bulk drug substance and pharmaceutical dosage forms. The method employs a high-efficiency chromatographic stationary phase and an aqueous-organic mobile-phase system with photodiode-array detection. Chromatographic variables including stationary phase, mobile-phase composition, flow rate, column temperature and detection wavelength are optimized to obtain suitable retention, peak symmetry, chromatographic efficiency and resolution. The method is evaluated for specificity, linearity, accuracy, precision, sensitivity, robustness, solution stability and forced degradation. In the supplied validation study, zalcitabine showed a retention time of 2.18 ± 0.02 minutes, linearity over 10–70 µg/mL with R² = 0.9994, recovery of 99.21–100.14%, repeatability %RSD of 0.48%, intermediate precision %RSD of 0.71%, LOD of 0.12 µg/mL and LOQ of 0.38 µg/mL. The method is therefore suitable, subject to appropriate regulatory and experimental verification, for routine pharmaceutical quality-control analysis and stability studies.
Disclaimer: Curated by HT Syndication.
