LC Method Development and Validation for the Determination of Ropivacaine Hydrochloride in Bulk Drug and Pharmaceutical Formulations
- Authors: Chigurupati S.1, Appala R.N.2, Selvarajan K.K.3, Khaw C.H.1, Teoh C.F.1, Batumanathan L.1, Mohammad J.I.4
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Affiliations:
- Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
- Department of Pharmaceutical Chemistry, Sultan Ul Uloom College of Pharmacy
- Faculty of Pharmacy, Universiti Teknologi MARA
- Faculty of Medicine, AIMST University, Semeling
- Issue: Vol 51, No 1 (2017)
- Pages: 71-80
- Section: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244508
- DOI: https://doi.org/10.1007/s11094-017-1561-z
- ID: 244508
Cite item
Abstract
Asimple liquid chromatography method has been developed for the assay of ropivacaine hydrochloride in raw material and final products. The chromatographic separation employs gradient elution using C8 column, mobile phase consisting of solvent [A] (monobasic phosphate buffer adjusted to pH 2.5) and solvent [B] (acetonitrile) delivered at a flow rate of 1.0 mL/min. The analytes were detected at 220 nm and peak purity was examined using a photodiode array detector. The proposed method was validated to demonstrate its selectivity, accuracy, precision, robustness, and linearity within a given range. The limits of detection and quantitation were 0.1 and 0.5 g/mL, respectively. The specificity of the method was investigated under various stress conditions, including hydrolysis, heat, oxidation, and photolysis. Stress testing showed degradants, which were well separated from the parent compound proving the stability and indicating capacity of the method.
About the authors
Sridevi Chigurupati
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Author for correspondence.
Email: sridevi.phd@gmail.com
Malaysia, Bedong, Kedah, 08100
Raju Nemela Appala
Department of Pharmaceutical Chemistry, Sultan Ul Uloom College of Pharmacy
Email: sridevi.phd@gmail.com
India, Hyderabad, Telangana, 500034
Kesavanarayanan Krishnan Selvarajan
Faculty of Pharmacy, Universiti Teknologi MARA
Email: sridevi.phd@gmail.com
Malaysia, Puncak Alam, Selangor, 42300
Chu How Khaw
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malaysia, Bedong, Kedah, 08100
Chun Foo Teoh
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malaysia, Bedong, Kedah, 08100
Livyashry Batumanathan
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malaysia, Bedong, Kedah, 08100
Jahidul Islam Mohammad
Faculty of Medicine, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malaysia, Bedong, Kedah, 08100