Author(s):
Garimi Tirumala Jyothesh Kumar, B.S.A. Andrews, V D N Kumar Abbaraju, P. Sunil Reddy, Nutulapati V.S. Venugopal, Kancharla Vijayalakshmi
Email(s):
vabbaraj@gitam.edu , sbethapu@gitam.edu
DOI:
10.52711/0974-360X.2025.00058 
Address:
Garimi Tirumala Jyothesh Kumar1, B.S.A. Andrews1*, V D N Kumar Abbaraju1*, P. Sunil Reddy2, Nutulapati V.S. Venugopal3, Kancharla Vijayalakshmi4
1,2Analytical Science and Technology, Generics, IPDO, Dr. Reddy's Laboratories, Bachupally, Hyderabad-500090 India.
1,3Department of Chemistry, GSS, GITAM University, Visakhapatnam – India – AP – 530045.
4Research Fellow in Internal Medicine Department in Mayo Clinic 4500 San Pablo Road, Jacksonville, Florida 32224.
*Corresponding Author
Published In:
Volume - 18,
Issue - 1,
Year - 2025
ABSTRACT:
A validated reverse-phase ultra-performance liquid chromatography (UPLC) method has been developed for the precise determination of impurities in Clidinium Bromide (CDB) and Chlordiazepoxide Hydrochloride (CDH) Capsules. This study focuses on the separation of impurities, namely Benzylic acid (BZY) related to Clidinium, Chlordiazepoxide Related Compound A (CDRC-A), and Chlordiazepoxide Related Compound C (CDRC-C). The Water’s H-Class UPLC system, equipped with a PDA Detector, was employed with a 15µL loop size, operating at a detection wavelength of 215 nm in gradient mode with a flow rate of 0.3 mL/min, resulting in a total run time of 55 min. The chromatographic separation utilized a Waters Acquity UPLC BEH C18 column (150 mm × 2.1 mm i.d., 1.7 µm particle size) at a column temperature of 55°C. The method demonstrated robustness and accuracy with retention times for CDB (4.4), BZY (5.2), CDRC-A (8.5), CDH (12.1), and CDRC-C (33.8). The % Accuracy at 100% for CDB is 98.2, BZY is 0.0765, CDRC-A is 0.1350, CDH is 98.2 and CDRC-C is 101.0 respectively. LOQ values for CDB is 0.0756, BZY is 0.0765, CDRC-A is 0.1464, CDH is 0.0749 and CDRC-C is 0.1932. Linear responses were observed for all impurities, including CDB and CDH. This validated UPLC method is deemed more appropriate to regular QC analysis as well as Stability study analysis of CDB and CDH Capsules formulations.
Cite this article:
Garimi Tirumala Jyothesh Kumar, B.S.A. Andrews, V D N Kumar Abbaraju, P. Sunil Reddy, Nutulapati V.S. Venugopal, Kancharla Vijayalakshmi. Efficient Separation of Related Substances in Clidinium Bromide and Chlordiazepoxide Hydrochloride Capsules using Reversed-phase Ultra-performance Liquid Chromatography. Research Journal of Pharmacy and Technology. 2025;18(1):372-8. doi: 10.52711/0974-360X.2025.00058
Cite(Electronic):
Garimi Tirumala Jyothesh Kumar, B.S.A. Andrews, V D N Kumar Abbaraju, P. Sunil Reddy, Nutulapati V.S. Venugopal, Kancharla Vijayalakshmi. Efficient Separation of Related Substances in Clidinium Bromide and Chlordiazepoxide Hydrochloride Capsules using Reversed-phase Ultra-performance Liquid Chromatography. Research Journal of Pharmacy and Technology. 2025;18(1):372-8. doi: 10.52711/0974-360X.2025.00058 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-1-58
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