Simple reversed phase high performance liquid chromatography method for the estimation of related substances, assay of cabozantinib and nivolumab and its application to issolution studies
By: Podili, Bhavani
.
Contributor(s): Seelam, M.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2021Edition: Vol.83(4), July-Aug.Description: 701-713p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: The present work describes the development and subsequent validation of a novel, simple, selective and
stability indicating gradient reversed phase high performance liquid chromatography method for the
quantitative determination of related substances, assay of cabozantinib and nivolumab and its application
to dissolution studies. The chromatographic method was optimized using the impurity-spiked solution.
A good resolution between the peaks was achieved under selected chromatographic conditions. The
separation was accomplished on an X-Bridge C18, 150×4.6 mm, 3.5 μ column connected to a photo diode
array detector using 0.1 % orthophosphoric acid in water as mobile phase A and acetonitrile as mobile
phase B, under gradient elution. The mobile phase flow rate was maintained at 1.0 ml/min. The detection
of the constituents was done at 216 nm using a ultra-violet detector. Recovery studies were satisfactory
and the correlation coefficient for two active pharmaceutical ingredients and their related substances,
0.999 indicates the linearity of the method within the limits. Limit of detection and limit of quantification
for all impurities and cabozantinib and nivolumab were established with respect to the test concentration.
Specificity, accuracy, precision, ruggedness and robustness were determined as part of the method
validation. The performance of the method was validated according to the current International Council
for Harmonisation requirements. Moreover, the dissolution study was performed on active pharmaceutical
ingredients to estimate the recovery using the same method. Validation of the developed reversed phase
high performance liquid chromatography procedure revealed that all the degradation products formed
during stress conditions and related impurities were well separated from their active pharmaceutical
ingredients and peaks were well resolved from each other with appropriate retention time. The method
was characterized by good linearity, specificity, low values of limit of detection and quantisation, accuracy,
precision, ruggedness and robustness. All statistical results were within the acceptance criteria and the
proposed method is simple, fast, accurate, precise and reproducible. Hence, it can be applied for routine
dissolution analysis and employed for quality control of drug samples during stability studies.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2022-0919 |
The present work describes the development and subsequent validation of a novel, simple, selective and
stability indicating gradient reversed phase high performance liquid chromatography method for the
quantitative determination of related substances, assay of cabozantinib and nivolumab and its application
to dissolution studies. The chromatographic method was optimized using the impurity-spiked solution.
A good resolution between the peaks was achieved under selected chromatographic conditions. The
separation was accomplished on an X-Bridge C18, 150×4.6 mm, 3.5 μ column connected to a photo diode
array detector using 0.1 % orthophosphoric acid in water as mobile phase A and acetonitrile as mobile
phase B, under gradient elution. The mobile phase flow rate was maintained at 1.0 ml/min. The detection
of the constituents was done at 216 nm using a ultra-violet detector. Recovery studies were satisfactory
and the correlation coefficient for two active pharmaceutical ingredients and their related substances,
0.999 indicates the linearity of the method within the limits. Limit of detection and limit of quantification
for all impurities and cabozantinib and nivolumab were established with respect to the test concentration.
Specificity, accuracy, precision, ruggedness and robustness were determined as part of the method
validation. The performance of the method was validated according to the current International Council
for Harmonisation requirements. Moreover, the dissolution study was performed on active pharmaceutical
ingredients to estimate the recovery using the same method. Validation of the developed reversed phase
high performance liquid chromatography procedure revealed that all the degradation products formed
during stress conditions and related impurities were well separated from their active pharmaceutical
ingredients and peaks were well resolved from each other with appropriate retention time. The method
was characterized by good linearity, specificity, low values of limit of detection and quantisation, accuracy,
precision, ruggedness and robustness. All statistical results were within the acceptance criteria and the
proposed method is simple, fast, accurate, precise and reproducible. Hence, it can be applied for routine
dissolution analysis and employed for quality control of drug samples during stability studies.
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