LC Method Development and Validation for the Determination of Ropivacaine Hydrochloride in Bulk Drug and Pharmaceutical Formulations
- Autores: Chigurupati S.1, Appala R.2, Selvarajan K.3, Khaw C.1, Teoh C.1, Batumanathan L.1, Mohammad J.4
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Afiliações:
- 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
- Edição: Volume 51, Nº 1 (2017)
- Páginas: 71-80
- Seção: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244508
- DOI: https://doi.org/10.1007/s11094-017-1561-z
- ID: 244508
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Resumo
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.
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Sobre autores
Sridevi Chigurupati
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Autor responsável pela correspondência
Email: sridevi.phd@gmail.com
Malásia, Bedong, Kedah, 08100
Raju Appala
Department of Pharmaceutical Chemistry, Sultan Ul Uloom College of Pharmacy
Email: sridevi.phd@gmail.com
Índia, Hyderabad, Telangana, 500034
Kesavanarayanan Selvarajan
Faculty of Pharmacy, Universiti Teknologi MARA
Email: sridevi.phd@gmail.com
Malásia, Puncak Alam, Selangor, 42300
Chu Khaw
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malásia, Bedong, Kedah, 08100
Chun Teoh
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malásia, Bedong, Kedah, 08100
Livyashry Batumanathan
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malásia, Bedong, Kedah, 08100
Jahidul Mohammad
Faculty of Medicine, AIMST University, Semeling
Email: sridevi.phd@gmail.com
Malásia, Bedong, Kedah, 08100