MUMBAI, India, Aug. 10 -- Intellectual Property India has published a patent application (202621075766 A) filed by Mr. Harsh Kumar Brahmbhatt; and Mr. Mahavir Kumar Sharma on June 18, 2026, for A Novel Reverse Phase High Performance Liquid Chromatographic Method For Quantitative Determination Of Doxorubicin Hydrochloride.
Inventors include Mr. Harsh Kumar Brahmbhatt; and Mr. Mahavir Kumar Sharma.
The application for the patent was published on July 31, 2026, under issue no. 31/2026.
Abstract: The present invention relates to a reverse phase high performance liquid chromatographic (RP-HPLC) method for quantitative determination of Doxorubicin Hydrochloride in bulk drug substances and pharmaceutical formulations. The method employs a C18 chromatographic column having dimensions of 250 mm × 4.6 mm and particle size of 5 µm. Chromatographic separation is achieved using a mobile phase comprising ammonium acetate buffer adjusted to pH 4.5 and methanol in a ratio of 65:35 v/v at a flow rate of 1.0 mL/min. Detection is performed at 254 nm using a UV detector and an injection volume of 10 µL. Doxorubicin Hydrochloride is eluted at a retention time of approximately 4.85 minutes. The method demonstrates excellent specificity, linearity over the concentration range of 10–70 µg/mL, precision, accuracy, robustness and sensitivity. The method provides a limit of detection of about 0.18 µg/mL and a limit of quantification of about 0.55 µg/mL. The validated method is suitable for routine assay determination, quality control testing and quantitative analysis of Doxorubicin Hydrochloride in bulk drug substances and pharmaceutical dosage forms.
Disclaimer: Curated by HT Syndication.
