MUMBAI, India, July 24 -- Intellectual Property India has published a patent application (202641086464 A) filed by Badikela Rama Krishna on July 14, 2026, for Novel Development And Validation Of Stability-Indicating Rp- Hplc Method For The Estimation Of Tafamidis In Bulk Drug And Marketed Pharmaceutical Dosage Forms.

Inventors include Dr. Badikela Rama Krishna; Venkateswarlu Guddeti; Dr. Shaik Harun Rasheed; Dr. V. Ravi Kumar.; Dr. Sayyad Mustak.; Bijjala. Vignan.; B. Vasudeva.; B. Rajyalakshmi; B. Chaithanya; and Chahat Baghel.

The application for the patent was published on July 17, 2026, under issue no. 29/2026.

Abstract: A simple, rapid, accurate, precise, economical, and stability-indicating reverse-phase high-performance liquid chromatographic (RP- HPLC) method was developed and validated for the estimation of Tafamidis in bulk drug and marketed pharmaceutical dosage forms. Chromatographic separation was achieved on a Phenomenex Gemini ODS C18 column (250 × 4.6 mm, 5 µm) using methanol and phosphate buffer (25:75, v/v) as the mobile phase at a flow rate of 1.0 mL/min, with detection at 312 nm using a PDA detector. The method was validated according to ICH Q2(R2) guidelines for system suitability, specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method exhibited excellent linearity, satisfactory accuracy, and high precision with low %RSD values. Robustness studies confirmed the reliability of the method under minor deliberate variations in chromatographic conditions. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic stress conditions demonstrated the stability-indicating capability of the method by effectively separating Tafamidis from its degradation products. The validated method is suitable for routine quality control and stability analysis of Tafamidis in pharmaceutical dosage forms. Keywords: Tafamidis, RP-HPLC, Stability-indicating method, Method validation, ICH Q2(R2), Quality control.

Disclaimer: Curated by HT Syndication.