International Journal of Drug Delivery Technology
Volume 15, Issue 1

Analytical Method Development and Validation of a Novel RP-HPLC Method for Simultaneous Quantification of Xanomeline and Trospium Chloride in Pharmaceutical Dosage Form

Pasupuleti Laxmiprasanna1, Chandan R S1* Haritha Reddy Nagidi2 Nithin Vidiyala3

1Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka-570015,

2Department of Pharmaceutical Analysis, Care College of Pharmacy, Oglapur, Warangal, Telangana, India

 3Cerevel Therapeutics, 222 Jacobs St. Suite 200, Boston, Massachusetts 02141, United States

Received: 21st Nov, 2024; Revised: 19th Feb, 2024; Accepted: 5th Mar, 2024; Available Online: 25th Mar, 2025

ABSTRACT

This study aimed to develop and validate a novel RP-HPLC method for the simultaneous estimation of Xanomeline and Trospium Chloride in combination dosage forms, addressing the lack of existing methods for their concurrent analysis. Xanomeline, a muscarinic receptor agonist for schizophrenia, and Trospium Chloride, an anticholinergic for mitigating adverse peripheral effects, are combined for therapeutic synergy. The method utilized a Kromasil C18 column with a mobile phase of acetonitrile and 0.1% formic acid (40:60), a flow rate of 1 mL/min, and a detection wavelength of 231 nm. Validation parameters followed ICH guidelines, demonstrating specificity, linearity (R² = 0.99979 for Xanomeline and 0.99988 for Trospium Chloride), precision (%RSD < 0.8), and robustness under varied chromatographic conditions. Forced degradation studies confirmed the method's stability-indicating capability, with Xanomeline showing maximum degradation under peroxide (14.1%) and alkali (12.2%) stress, while Trospium Chloride exhibited significant degradation under peroxide (14%) and acid (11.2%). Accuracy studies revealed mean recoveries of 99.7%–100.0% for Xanomeline and 99.4%–100.0% for Trospium Chloride. The method is suitable for routine analysis, ensuring quality control for combination therapies.

Keywords: Xanomeline, Trospium Chloride, RP-HPLC, Stability Indicating, Forced Degradation, Validation.

How to cite this article: Pasupuleti Laxmiprasanna, Chandan R S Haritha Reddy Nagidi Nithin Vidiyala. Analytical Method Development and Validation of a Novel RP-HPLC Method for Simultaneous Quantification of Xanomeline and Trospium Chloride in Pharmaceutical Dosage Form.  International Journal of Drug Delivery Technology. 2025;15(1):119-25. doi: 10.25258/ijddt.15.1.16

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