INTRODUCTION:

Dasatinib is a “tyrosine kinase inhibitor” type of drug with several targets, it inhibits “BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ”¹. Myelosuppression, disease related to bleeding, fluid accumulation, cardiovascular toxicity, arterial hypertension, dermatologic reactions, tumour lysis syndrome, and hepatotoxicity" are other actions linked to dasatinib use². Additionally, it may result in severe reactions related to bone growth and development in paediatric patients as well as embryo-fatal toxicity.^3,4

The Chemical name of this drug is “N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamide.”⁵

The powder form of dasatinib is white in color. This drug is soluble in DMSO and methanol and poorly soluble in water.^6,7 There are oral preparations available in tablet form.⁸

For the management of myeloid leukemia, dasatinib oral dose is 20-140mg daily, in once or twice divided doses.

In individuals suffering from chronic myeloid leukaemia (CML) is deregulation of BCR-ABL's tyrosine kinase function results in the development, multiplication, and survival of malignant hematopoietic cells.⁹ The mechanism of action of dasatinib is in chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia as a small-molecule multikinase inhibitor that can be taken orally, dasatinib suppresses the development of cell lines that overexpress BCR-ABL. In clinical studies, 1% of patients treated with dasatinib exhibited a QTcF greater than 500 ms, while less than 1% of patients experienced QTc prolongation as an adverse event.¹⁰

Primary goal of this study was to locate an appropriate method of analysis by UV-Spectrophotometer. The solubility of the drug dasatinib was studied and compared in-between three different types of body fluids with three different pHs those are physiological buffer, stomach buffer and intestinal buffer. The three different types of buffers represent the three different body solutions. The best suitable solution was found out and the best suitable site for administration was determined.

MATERIALS AND METHODS:

Materials:

Dasatinib was procured from CIPT College. Sodium chloride, Sodium dihydrogen phosphate and di-sodium nitrogen phosphate and potassium chloride, hydrochloric acid, pepsin, sodium hydroxide, calcium chloride, magnesium chloride, and sodium bicarbonate were given by CIPT College. The grade of all other chemicals utilized was analytical grade.

Spectrophotometric analysis was done with a double beam UV visible Spectrophotometer with a 10 millimeters path length in quartz cell, for analytical purpose¹¹.

Preparation of physiological simulator buffer solution (7.4 pH):

0.8g of NaCl was precisely weighed, then dissolved into 10ml distilled water. Sodium di-hydrogen phosphate, di-sodium hydrogen phosphate and KCl were accurately weighed and put into the solution¹². And the volume of solution contained up-to 100millilitres of distilled water. Then the pH 7.4 was adjusted. This 100ml solution was applied as the diluent^13,14.

Preparation a standard curve of dasatinib in physiological solution (pH 7.4):

10milligrams of the drug was diluted into ten millilitres of the buffer solution to get 1mg per ml or 1000mcg/ml stock solution¹⁵. Then further serial dilutions were done with the previously made buffer, to prepare the concentration range of 2, 4, 6, 8 and 10mcg/ml. And the absorption was determined using a UV spectrophotometer at 323nm¹⁶ against a blank of pH 7.4 phosphate buffer. The standard calibration curve was obtained by plotting the absorbance with concentration (μg/mL).

Preparation of gastric simulator buffer solution (1.2 pH):

0.2gm of NaCl was weighed accurately and dissolved into 0.7ml of HCl. And 0.32g of pepsin was precisely measured and dissolved in 10ml of distilled water¹⁷ and the volume was filled up to 100ml by pouring more distilled water. Then the PH was maintained to 1.2 by adding HCl¹⁸. This 100ml solution was used as the diluent.

Preparation of standard curve of dasatinib in gastric simulator buffer solution (pH 1.2):

Ten milligrams of the drug was diluted into 10ml of the buffer solution to get 1mg/ml or 1000mcg/ml stock solution¹⁹. Then further serial dilutions were done to prepare the concentration range of 2, 4, 6, 8 and 10mcg /ml. And the absorption was evaluated in comparison to pH 1.2buffer as the blank at utilizing a UV spectrophotometer, 323nm²⁰. The “standard calibration curve” was obtained by plotting the absorbance with concentration (μg/mL).

Preparation of intestine simulator buffer solution (6.8 pH) :

0.1gm of NaOH, 1.19gm NaCl, 0.1g of KCl, 0.04gm of CaCl₂, 0.02gm MgCl_, 0.2gm of sodium bicarbonate were weighed accurately, and dissolved into 10ml of water and then a 100ml amount was added which was distilled water²¹. Then The pH was changed to 6.8. This 100ml solution was applied as the diluent.

Preparation of standard curve of dasatinib in intestinal solution (pH 6.8):

10 mg of the drug was diluted into 10 ml of the buffer solution to get 1mg/ml or 1000 μg/mL stock solution²². Then further serial dilutions were done to have the concentration range of 2,4,6,8 and 10 μg/mL. And absorption was measured against pH 6.8 buffer as the blank at 323 nm using a UV-spectrophotometer²³. The “standard calibration curve” was created by plotting the absorbance versus the concentration (μg/mL).

RESULT:

The purpose of this investigation was to determine the best appropriate solution for developing a simple and precise UV-spectrophotometric method and to select a suitable absorption site for dasatinib. This investigation includes figuring out the concentration of the drug in three types of body fluids spectrophotometrically.

The all three concentrations against absorbance standard curve graphs, determined by UV spectrophotometer, of the drug dasatinib, in three different buffer media was observed and comparison was done in-between them. The simulator fluid which could stabilize the region with the highest drug concentration was chosen to be the focus of the administration of adjusted dose forms of dasatinib. Findings and discussions of the above study is presented below.

Table 1: Calibration curve readings of dasatinib in pH 7.4 buffer at 323 nm

Concentration (mcg/ml)	Absorbance at 223 nm
0	0
2	0.11
4	0.18
6	0.254
8	0.35
10	0.452

Figure 1: Standard curve of dasatinib in pH 7.4 buffer at 323 nm.

Table 2: Calibration curve readings of dasatinib in pH 1.2 buffer at 323 nm

Concentration (mcg/ml)	Absorbance at 223 nm
0	0
2	0.242
4	0.398
6	0.61
8	0.811
10	0.987

Figure 2: Standard curve of dasatinib in pH 1.2 buffer at 323nm.

Table 3: Calibration curve readings of dasatinib in pH 6.8 buffer at 223 nm

Concentration (mcg/ml)	Absorbance at 323 nm
0	0
2	0.059
4	0.102
6	0.134
8	0.178
10	0.214

Figure 3: Standard curve of dasatinib in pH 6.8 buffer at 323 nm.

Table 4: Comparison between calibration curve of dasatinib, in three body fluids, at 323 nm

Concentration (mcg/ml)	Physiological solution (7.4 pH)	Gastric solution (1.2pH)	Intestinal solution (6.8pH)
0	0	0	0
2	0.11	0.242	0.059
4	0.18	0.398	0.102
6	0.254	0.61	0.134
8	0.35	0.811	0.178
10	0.452	0.987	0.214

Figure 4: Comparison between Standard curves of dasatinib, in three body fluids, at 323 nm

From the above comparison between three different pH buffers, we can see that the dasatinib drug is mostly soluble in 7.4 pH phosphate buffer solution.

Sensitivity:

The formula LOD = 3*σ/ S and LOQ = 10*σ/ S were utilized for calculating the limits of detection and limit of quantification, respectively. Here sigma signifies the standard deviation of intercept and S is referring the slope. The LOD of gastric fluid and intestinal fluid and physiological It was discovered that fluid 0.3968µg/ml, 0.375µg/ml and 0.3158µg/ml respectively. The LOQ of gastric fluid intestinal fluid and physiological It was discovered that fluid was 1.2025µg/ml, 1.30µg/ml and 1.9832µg/ml respectively.

DISCUSSION:

According to figure 4, from the comparison between three different pH buffers, we can conclude that the dasatinib drug is mostly soluble in 1.2 pH phosphate buffer solution.

Figure 4 displays the solubility of dasatinib in different bodily fluids. It was discovered through solubility research that exhibited the maximum solubility in the gastric fluid. And in the intestinal and, solubility is intermediate and lowest respectively. So, the most suitable buffer for UV Spectrophotometric analysis of the drug dasatinib would be the gastric buffer of pH 1.2.

CONCLUSION:

The primary goal of the research was to design the most suitable UV-spectrophotometric determination method and to ascertain the body's appropriate absorption site for the creation of an appropriate adjusted dosage form for the medication dasatinib. The comparison of three different body fluids solubility of the drug was done. The drug in each body fluid was assessed using spectrophotometry. The results of UV Spectrophotometry analysis verified that there was a higher drug concentration in the gastric fluid, compared to physiological fluid and intestinal fluid. Therefore, the formulation would be changed in a manner that would dosage form will deliver the maximum drug into the gastric fluid or the stomach.

CONFLICT OF INTEREST:

The authors not having any conflicts of interest regarding this thorough investigation.

ACKNOWLEDGMENTS:

The authors are thanking CIPT and AHS college authority for their kind support during all lab studies.

REFERENCES:

1. Ravisankar P, Anusha S, Babu PS. Development and validation of UV-spectrophotometric method for determination of dasatinib in bulk and pharmaceutical dosage form and its degradation behaviour under various stress conditions. Int. J. Pharm. Sci. Rev. Res. 2020; 53:45-50.

2. Nuli MV, Rekulapally VK. Overall review on analytical method development and validation of Dasatinib. International Journal of Pharmacognosy and Chemistry. 2023 Mar 31:27-34.

3. Mittha J, Habib B. UV spectrophotometric method development and validation of dasatinib in bulk and formulation. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):203-6.

4. Bayas JP, Sumithra M. Analytical method development and validation of Dasatinib in Bulk and pharmaceutical formulation using quality by design. Research Journal of Pharmacy and Technology. 2021;14(3):1591-6.

5. Sultana M, Rizwana DI. Stability indicating method development and validation for simultaneous estimation of dasatinib and lenvatinib by using uplc in pharmaceutical dosage form. World J Pharm. 2020 Sep 21;9:1548-60.

6. Shi M, Wang L, Li P, Liu J, Chen L, Xu D. Dasatinib–SIK2 binding elucidated by homology modeling, molecular docking, and dynamics simulations. ACS omega. 2021 Apr 15;6(16):11025-38.

7. Reddy A, Parthiban S, Vikneswari A, Senthilkumar G. A modern review on solid lipid nanoparticles as novel controlled drug delivery system. Int. J. Res. Pharm. Nano Sci. 2014;3(4):313-25.

8. Müller RH, Mäder K, Gohla S. Solid lipid nanoparticles (SLN) for controlled drug delivery–a review of the state of the art. European Journal of Pharmaceutics and Biopharmaceutics. 2000 Jul 3;50(1):161-77.

9. Trevaskis NL, Charman WN, Porter CJ. Lipid-based delivery systems and intestinal lymphatic drug transport: a mechanistic update. Advanced Drug Delivery Reviews. 2008 Mar 17; 60(6): 702-16.

10. Yadav P, Soni G, Mahor A, Alok S, Singh PP, Verma A. Solid lipid nanoparticles: An effective and promising drug delivery system-A review. International Journal of Pharmaceutical Sciences and Research. 2014 Apr 1; 5(4): 1152.

11. Rathod SD, Patil PM, Jadhav SB, Chaudhari PD. UV spectrophotometric simultaneous determination of metformine hydrochloride and pioglitazone hydrochloride in combined dosage form. Asian Journal of Pharmaceutical Analysis. 2012; 2(1): 5-9

12. Madhu C, Swapna J, Spandana RS, Niharika I, Raj KR, Kalyan B, Rajarajeshwari M, Prathyusha T. Quantitative evaluation of carbohydrate levels in seeds for home use by UV-visible spectrophotometer. Asian Journal of Pharmacy and Technology. 2012; 2(3): 110-1.

13. Sourav Duari, Ayan Das, R.N. Pal. UV-Spectrophotometric Method Development and Determination of Suitable Medium for Lornoxicam by Comparing In-Between Three Body Fluids. Asian Journal of Pharmaceutical Analysis. 2025; 15(2): 75-9.

14. Ankit Sharma, S. K. Arora, Manoj Kumar Batra, Rakhi Khandelwal. Corrosion inhibition and Adsorption characteristics of 3,4,5-trihydroxy-n-(3,4-dimethoxy benzylidene) benzo hydrazide schiff base on aluminium in different concentration of Hydrochloric acid environment. Research Journal of Science and Technology. 2023; 15(4): 175-2.

15. S. B. Gondkar, Nikita S. Malekar, R.B.Saudagar. An Overview on Trends and Development of Niosomes as Drug Delivery. Research J. Topical and Cosmetic Sci. 2016; 7(2): 79-85.

16. Shabina Fatma, Kiran Kumari. Study of Narcotic substances present in different Biological samples. Research Journal of Science and Technology. 2023; 15(4): 203-4.

17. Tomasz W. Kamiński, Małgorzata Karbowska, Dariusz Pawlak. A Review of the Pharmacological properties of potential drugs for the treatment of stuttering from the past to the future. Asian J. Pharm. Res. 2018; 8(2): 104-109.

18. Manoj Kumar Ghosh, Harsha Tiwari. Heavy Metal Concentration in underground water due to Fly Ash at Janjgir Champa region in Chhattisgarh. Research Journal of Science and Technology. 2021; 13(2): 79-4.

19. S. D. Mankar, Sahil B. Shaikh. Microencapsulation: is an advance Technique of Drug formulation for Novel Drug Delivery System. Research J. Science and Tech. 2020; 12(3): 201-210.

20. Jyoti Prakash, Shweta Manan, Vinod Kumar. On Triply Diffusive Convection in Porous Medium: Darcy Brinkman Model. Research J. Science and Tech. 2017; 9(1): 127-130.

21. Jyoti Prakash, Rajeev Kuma, Prakash Chopra. On Triply Diffusive Convection Analogous to Stern type with Variable Viscosity. Research J. Science and Tech. 2017; 9(1): 111-114.

22. Manish Upadhyay. Depleting Groundwater Levels and Increasing Fluoride Concentration in Villages of Surajpur District, Chhattisgarh, India: Cost to Economy and Health. Research J. Science and Tech. 2012; 4(3): 122-128.

23. Shyam S Kumar, G. Gopalakrishnan, N. L. Gowrishankar. Design, Optimization and in vitro Characterization of Dasatinib loaded PLGA Nano carrier for Targeted cancer therapy: A Preliminary Evaluation. Research Journal of Pharmacy and Technology. 2021; 14(4): 2095-0.

Received on 24.04.2025 Revised on 31.05.2025

Accepted on 30.06.2025 Published on 08.10.2025

Available online from October 15, 2025

Asian Journal of Pharmaceutical Analysis. 2025; 15(4):263-266.

DOI: 10.52711/2231-5675.2025.00041

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