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| 005 | 20211122152913.0 | ||
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| 040 |
_aAIKTC-KRRC _cAIKTC-KRRC |
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| 100 |
_99942 _aKolla, Sudheer Babu |
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| 245 | _aChemometric Assisted Development and Validation of a Stability-indicating LC Method for Determination of Related Substances in Haloperidol Decanoate Injection | ||
| 250 | _aVol.55(3), Jul-Sep | ||
| 260 |
_aBanagalore _bAssociation of Pharmaceutical Teachers of India (APTI) _c2021 |
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| 300 | _a904-915p. | ||
| 520 | _aAim: Haloperidol decanoate injection is a phenyl butyl piperadine derivative with antipsychotic, neuroleptic, antiemetic effects and has multiple related substances as process and degradant impurities. Objectives: This study focuses on chemometric assisted liquid chromatographic approach to develop a stability indicating impurity profile of Haloperidol decanoate injection. Methodology: Dual experimental designs (combined mixture I-optimal design and response surface historical data design) were employed to resolve all thirteen known impurities of Haloperidol decanoate. Chromatographic separation was achieved on a Hypersil BDS C18 (100 x 4.0 mm) 3-μm column to attain separation of related compounds. Results: The optimum conditions for the chromatographic system resulted in a mobile phase consisting of tetra butyl ammonium hydrogen sulphate/ 1-decane Sulphonate sodium buffer solution and acetonitrile with linear gradient elution at a flow rate of 1.4 mL/min. Selectivity, forced degradation, linearity, accuracy and precision were demonstrated in a range of 0.75-30.0 μg/mL. Conclusion: The optimized method was able to resolve the ghost peak observed because of gradient change of mobile phase and is able to separate both polar and non-polar impurities within 60 min, in single method, with resolution of more than 2.0 between adjacent impurities. The inter-day precision for all impurities and haloperidol decanoate were evaluated and found to have a % RSD of less than 10. | ||
| 650 | 0 |
_94639 _aPHARMACEUTICS |
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_99943 _aVallabhaneni, Madhusudhan Rao |
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| 773 | 0 |
_tIndian journal of pharmaceutical education and research _dBengluru Association of Pharmaceutical Teachers of India (APTI) _x0019-5464 |
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| 856 |
_uhttps://www.ijper.org/sites/default/files/IndJPhaEdRes-55-3-904.pdf _yClick here |
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| 942 |
_2ddc _cAR |
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