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Stability Indicating RP-HPLC Method for the Estimation of Plerixafor and its
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| Author:
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PINGALI SRIDEVI, VINUTHA.K, MAHESH.K, AKSHITHA.M, BHAGAVAN RAJU.M , KEERTHI CHAND
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| Abstract:
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Developed and validated a stability indicating reversed phase high performance liquid chromatographic method (RPHPLC)
for the estimation of plerixafor and its impurities in bulk and parenteral dosage form. The method was carried
out using Zorbax eclipse C18 column (250 x 4.6mm, 5?m) with mobile phase-A and mobile phase-B, where mobile
phase-A consists of 1-Hexane sulphonic acid sodium salt buffer and mobile phase-B consists of Acetonitrile and water in
the ratio of 80:20 (v/v) under gradient mode with an injection volume of 10µL at flow rate of 1ml/min and the detection
was carried out at 210 nm. The retention time of the plerixafor for assay and RS method were found to be 14.17min
and 21.68min. The assay method showed linear response in the concentration range of 200-600µg/ml with a correlation
coefficient of 0.999 and for RS method in the concentration range of LOQ to 200% with a correlation coefficient of
0.998. The method precision for the determination of assay was below 2% RSD and the percentage recovery of
plerixafor was found to be 99.47. Plerixafor was subjected to stress conditions like acidic, alkaline and oxidation
degradations. The degradation products were well separated from each other and with the main peak. The proposed
method was validated as per ICH guidelines. The method was found to be linear, specific, precise and accurate.
Therefore, the proposed method can be used for the routine analysis of drug in the process control of bulk and
pharmaceutical formulation.
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| Keyword:
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Plerixafor, Potential impurities, RP-HPLC, Validation, Stability indicating
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| DOI:
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