MUMBAI, India, May 1 -- Intellectual Property India has published a patent application (202621026800 A) filed by Dr. Sunila Atul Pati; Neha Chandrashekhar Patil; Mrs. Amruta Nilesh Patil; Ms. Sulbha Gopal Patil; Mrs. Neha Prashant Patil; and Mrs. Mrunal Darshan Pendharkar, Shahada, Maharashtra, on March 7, for 'validated rp-hplc method for quantitative estimation of promethazine hydrochloride in pharmaceutical dosage forms.'
Inventor(s) include Dr. Sunila Atul Pati; Neha Chandrashekhar Patil; Mrs. Amruta Nilesh Patil; Ms. Sulbha Gopal Patil; Mrs. Neha Prashant Patil; and Mrs. Mrunal Darshan Pendharkar.
The application for the patent was published on May 1, under issue no. 18/2026.
According to the abstract released by the Intellectual Property India: "The present invention relates to a validated reverse phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative estimation of Promethazine Hydrochloride in bulk drug and pharmaceutical tablet dosage forms. Chromatographic separation is achieved using a C18 column (250 mm 4.6 mm, 5 m particle size) with a mobile phase consisting of acetonitrile and 0.1% trifluoroacetic acid in water (50:50 v/v) under isocratic conditions at a flow rate of 1.0 mL/min. Detection is carried out at 253 nm using a UV detector, with an injection volume of 20 L and column temperature maintained at 40 C. The retention time of Promethazine Hydrochloride is approximately 5.42 minutes. The method is validated in accordance with ICH guidelines for specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation. The method shows excellent linearity over 10-30 g/mL with correlation coefficient of 0.99998. Accuracy and precision results are within acceptable limits. The developed method is simple, sensitive, accurate, precise, robust, and suitable for routine quality control analysis of Promethazine Hydrochloride."
Disclaimer: Curated by HT Syndication.
