INTRODUCTION:

It is a 4-[(4-methylpiperazin-1-yl) methyl]-N-(4-methyl-3-{[4-(pyridin-3-yl) pyrimidin-2-yl] amino} phenyl) benzamide, imatinib mesylate. It is known for chronic myelogenous leukemia and acute lymphocytic leukemia that are philadephia chromosome positive, certain types of gastrointestinal stromal tumors, hypersinoiphilic syndrome, chronic eosinophilic leukemia, systemic mastocytosis and myelodysplastic syndrome.

According to the literature review several methods has been developed for drug, like spectroscopy methods^1-7. HPLC^8-22, and HPTLC²³. This extractive colorimetric can be used for the routine analysis. In the proposed methods optimization and validation of this method are reported.

Structure of imatinib mesylate

MATERIALS AND METHOD:

Instrument and reagents:

Spectral scan was made on a Shimadzu UV-spectrophotometer, model 1800 (Shimadzu, Japan) with spectral band width of 0.5 nm with automatic wavelength corrections by using a pair of 10 mm quartz cells.

Reference standard of imatinib mesylate was obtained from reputed firm with certificate of analysis.

Preparation of standard drug solutions:

10mg standard imatinib mesylate was weighed accurately and transferred to a 10ml volumetric flask and sonicated with 3ml of distilled water for 5minutes. The volume was made up to the mark with distilled water to give a stock solution of imatinib mesylate of concentration 1000μg/ml. From this solution, 1ml of solution was pipetted out and transferred into 10ml volumetric flask. The volume was made up to mark with distilled water to give a working standard solution of concentration 100μg/ml.

Preparation of reagent:

A 0.05% w/v Congo red, 0.25% eriochrome black T and 0.02% methyl orange solutions were prepared in distilled water respectively.

Potassium hydrogen phthalate buffer solution of pH 4.01was prepared in distilled water. Dilute hydrochloric acid was used to adjust desired pH of buffer solution.

Estimation from tablets:

Twenty tablets were weighed accurately and average weight of each tablet was determined. Powder equivalent to 10mg of imatinib mesylate was weighed and transferred in 100ml of volumetric flask. A 30ml of distilled water was added and sonicated for 15 minutes and filtered. The filtrate and washing were diluted up to the mark with distilled water to give concentration as 100 μg /ml. Such solution was used for analysis.

EXPERIMENTAL:

Method 1(with Congo red):

Into a series of separating funnels appropriate amount of the working standard drug solutions were pipetted out. To each funnel 1.0ml of buffer (pH= 3.9) and 4.0ml of 0.05 %w/v congo red were added. 10ml of chloroform was added to each funnel. The solutions were shaken for thorough mixing of the two phases and were allowed to stand for clear separation of the layers. The absorbance values of the chloroform layers were measured against their respective reagent blank at the wavelength of the maximum absorbance (λmax 420nm).

Method 2(with methyl orange):

Into a series of separating funnels appropriate amount of the working standard drug solutions were pipetted out. To each funnel 3.0ml of buffer (pH = 3.8) and 2.5ml of 0.2% w/v methyl orange were added. 10ml of chloroform was added to each funnel. The solutions were shaken for thorough mixing of the two phases and were allowed to stand for clear separation of the layers. The absorbance values of the chloroform layers were measured against their respective reagent blank at the wavelength of the maximum absorbance (λmax=430 nm).

Method 3(with Eriochrome black T)

Into a series of separating funnels appropriate amount of the working standard drug solutions were pipetted out.To each funnel 2.0ml of buffer (pH= 3.5) and 5.2ml of 0.025% w/v eriochrome black T were added. 10ml of chloroform was added to each funnel. The solutions were shaken for thorough mixing of the two phases and were allowed to stand for clear separation of the layers. The absorbance values of the chloroform layers were measured against their respective reagent blank at the wavelength of the maximum absorbance (λmax =500 nm).

Results of analysis are given in table 1.

Table 1: Values of results of optical and regression of drug

Parameter	Congo red	Methyl orange	Eriochrome black T
Detection Wavelength (nm)	490	430	500
Beer Law Limits (µg/ml)	4-24	2-16	2-14
Correlation coefficient(r²)	0.9999	0.9999	0.9998
Regression equation (y=b+ac)
Slope (a)	0.0125	0.0075	0.01111
Intercept (b)	0.0013	0.0001	0.0006

RESULTS:

The extractive spectrophotometric methods are popular due to their sensitivity in assay of the drug and hence ion pair extractive spectrophotometric methods have gain considerable attention for quantitative determination of many pharmaceutical preparations. These proposed methods are extractive spectrophotometric methods for the determination of Imatinib mesylate by using chloroform as solvent from its formulations i.e. tablets. The colour ion pair complexes formed are very stable. The working conditions of these methods were established by varying one parameter at time and keeping the other parameters fixed by observing the effect produced on the absorbance of the colour species. The various parameters involved for maximum colour development for these methods were optimized. The proposed methods were validated statistically and by recovery studies. The molar absorptivity show the sensitivity of methods while the precision was confirmed by %RSD (relative standard deviation). The optical characteristics such as absorption maxima (nm), co-relation coefficient (r) were calculated and are also summarized. Assay results of recovery studies are given in table 2 (A, B, C).

Table no 2: A (Congo red)

Amount of Sample Added in (µg/ml)	Amount of Standard Added in (µg/ml)	Total amount recovered	Percentage recovery (%)	Standard deviation	Percentage of relative standard deviation (C.O.V.)
4	0	4.019048	100.4762	0.014921	0.371248
8	4	8.022409	100.2801	0.108246	1.34929
12	8	12.0112	100.0934	0.105505	0.878386
16	12	16.01008	100.063	0.183196	1.144253
				Mean=0.102967	Mean= 0.935794

Table no 2:C (Eriochrome black T)

Amount of Sample Added in (µg/ml)	Amount of Standard Added in (µg/ml)	Total amount recovered	Percentage recovery (%)	Standard deviation	Percentage of relative standard deviation (C.O.V.)
2	0	2.01039	100.5195	0.006273	0.312045
2	2	4.012987	100.3247	0.008872	0.221078
2	4	6.011688	100.1948	0.006872	0.114312
2	6	8.012987	100.1623	0.008872	0.110718
				Mean= 0.007722	Mean= 0.189538

Results are in good in agreement with labelled value.

DISCUSSION:

The percent recovery obtained indicates noninterference from the common excipients used in the formulation. The reproducibility, repeatability and accuracy of these methods were found to be good, which is evidenced by low standard deviation. The proposed methods are simple, sensitive, accurate, precise and reproducible. They are directly applied to drug to form chromogen. Hence they can be successfully applied for the routine estimation of Imatinib mesylate, in bulk and pharmaceutical dosage form even at very low concentration and determination of stability of drug in formulation such as tablets. The strong recommendation is made here for the proposed methods for determination of Imatinib mesylate from its formulation.

ACKNOWLEDGMENT:

Authors express sincere thanks to the Principal, of D. G. Ruparel College, Mumbai.

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Received on 25.01.2026 Revised on 20.02.2026

Accepted on 16.03.2026 Published on 27.05.2026

Available online from May 30, 2026

Asian J. Research Chem.2026; 19(3):243-246.

DOI: 10.52711/0974-4150.2026.00037

This work is licensed under a Creative Commons Attribution-Non Commercial-Share Alike 4.0 International License. Creative Commons License.

Amount of Sample Added in (µg/ml)	Amount of Standard Added in (µg/ml)	Total amount recovered	Percentage recovery (%)	Standard deviation	Percentage of relative standard deviation (C.O.V.)
2	0	2.011318	100.5659	0.009087	0.451793
2	2	4.011984	100.2996	0.012969	0.323248
2	4	6.009654	100.1609	0.012647	0.21045
2	6	8.005659	100.0707	0.011947	0.149232
				Mean= 0.011662	Mean= 0.28368