Development and validation of stability indicating high performance liquid chromatography method for related substances of imatinib mesylate
By: Pandey, K. P
.
Contributor(s): Singh, C. L.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2022Edition: Vol.84(2), Mar-Apr.Description: 465-476p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: In the present work high performance liquid chromatography method was developed and validated
for imatinib mesylate and its related substances. The analyzed active pharmaceutical ingredient and its
impurities were separated by Atlantis T3 (150 mm×4.6 mm), 3 μm column with ultraviolet detection at
230 nm. The mobile phase has been used in specific composition (50:50, v/v, organic and inorganic) that was
prepared using methanol and buffer (0.01 M of 1-Octane sulphonic acid with 0.2 % trifluoroacetic acid).
The results of proposed method were analyzed and validated as per International council on harmonisation
guidelines. The percentage relative standard deviation was observed as 1.15 % for system precision that
was found within the limit. The method was found to be specific as there was no interference between
blank, imatinib mesylate and impurities. The limit of detection and quantitation was found 0.383 and
1.15 ppm respectively. The regression coefficient (r2) of imatinib mesylate and its impurities was found
to be 0.999. Recovery results of impurities imatinib-piperazine-n-oxide and n-desmethyl-imatinib were
found 107.70 % and 99.30 % against standard which was within 80 %-120 % acceptance criteria. The
molecule was stable in all the stress conditions such as acid, base, oxidation, thermal and also in analytical
solution. Thus, proposed method was found to be sensitive, accurate, precise, reproducible and offered
good column life and also beneficial for study of impurities.
| 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 | 2022-2188 |
In the present work high performance liquid chromatography method was developed and validated
for imatinib mesylate and its related substances. The analyzed active pharmaceutical ingredient and its
impurities were separated by Atlantis T3 (150 mm×4.6 mm), 3 μm column with ultraviolet detection at
230 nm. The mobile phase has been used in specific composition (50:50, v/v, organic and inorganic) that was
prepared using methanol and buffer (0.01 M of 1-Octane sulphonic acid with 0.2 % trifluoroacetic acid).
The results of proposed method were analyzed and validated as per International council on harmonisation
guidelines. The percentage relative standard deviation was observed as 1.15 % for system precision that
was found within the limit. The method was found to be specific as there was no interference between
blank, imatinib mesylate and impurities. The limit of detection and quantitation was found 0.383 and
1.15 ppm respectively. The regression coefficient (r2) of imatinib mesylate and its impurities was found
to be 0.999. Recovery results of impurities imatinib-piperazine-n-oxide and n-desmethyl-imatinib were
found 107.70 % and 99.30 % against standard which was within 80 %-120 % acceptance criteria. The
molecule was stable in all the stress conditions such as acid, base, oxidation, thermal and also in analytical
solution. Thus, proposed method was found to be sensitive, accurate, precise, reproducible and offered
good column life and also beneficial for study of impurities.
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