YSPM, YTC, Faculty of Pharmacy, Satara-415011.
One of the enhancement techniques is hydrotropic solubilization, which uses hydrotropes like sodium citrate, sodium benzoate, urea, etc., to greatly increase solubility. This method has several advantages, such as not requiring organic solvents, chemically modifying hydrophobic drugs, or preparing emulsion systems.This study aims to use hydrotropy to a specific problem: how to make the medicine ibuprofen more soluble in 0.1 M ammonium acetate.Ionic organic salts considered as hydrotropic agent.These days, hydrotropic agents are being utilized to increase the therapeutic efficiency and bioavailability of poorly water-soluble pharmaceuticals by generating a variety of dosage forms, such as injections, mouth-dissolving tablets, and solid dispersions.
Hydrotropy is a solubilization phenomena whereby addition of significant concentration of second solute increases the water solubility of another solute.The chemical structure of the traditional Neuberg’s hydrotropic salts [sodium benzoate, proto-type] comprises generally of two key elements, an anionic group and a hydrophobic aromatic ring or ring system. The pharmacopoeia filed solubility in terms of number of milliliters of solvent required to dissolve 1g of solute. If exact solubility’s are not known, the pharmacopoeia provides general terms to explain a given range.
MATERIAL AND METHODS:-
Analysis of Salicylic acid bulk drug by IP method:-
About 300 mg of salicylic acid bulk drug was accurately weighed and dissolved in 50 ml of ethanol ) After adding 20 ml distilled water 25 ml of water was and and titrated with 0.1 M sodium hydroxide phenol red solution as indicator. Each ml of 0.1 M sodium hydroxide is equivalent to 0.013812 g of Salicylic acid. Drug content were determined (n=3) and presented in Table A. [1]
Analysis of Salicylic Acid bulk drug by the proposed method:-
About 300 mg of Salicylic Acid bulk drug as weighed and transferred to 250 ml conical flask.50 ml of a solution of 0.1 M Ammonium acetate was added and the flask was shaken for about 5 min to dissolve the drug. Titration was performed with 0.1 M sodium hydroxide using phenol red as indicator. Blank titration was performed for necessary correction. Each ml of 0.1 M sodium hydroxide is equivalent 0.013812 g of Salicylic acid. To drug content were determined (N=3) and presented in Table A.
RESULT AND DISCUSSION:-
Results of solubility experiments of salicylic acid demonstrated that enhancement in solubility in a hydrotropic solution containing 0.1 M was more than as compared to its solubility in distilled water. It is evident from the Table A. that the values of mean percent of Salicyclic acid estimated in the drug sample was by the Indian Pharmacopoeia and proposed titrimetric method respectively. The amounts of drug estimated by Indian Pharmacopoeia and proposed titrimetric method (Table A) are very close to each other and very near to 100.0mg, indicating the accuracy of the proposed method of analysis. Low values of deviation, percent coefficient of variation and standard error (table A) further validated the proposed titrimetric method.
TABLE-: A Analysis data of bulk drug sample with statistical evaluation (n=3)
|
Amount of bulk drug taken (mg) |
Method of analysis |
Percent drug estimated (mean ± SD ) |
Coefficient of variation (%) |
Standard error |
|
300 |
IPM |
100.213 ± 0.5741 |
0.3289 |
0.1903 |
|
300 |
PTM |
100.253 ± 0.7237 |
0.7818 |
0.4516 |
(IPM- INDIAN OHARAMCOPIEA METHOD, PTM- PROPOSED TRITRIMETRIC METHOD)
CONCLUSION:-
In this, concluded that the proposed method is new, simple, environmentally friendly, accurate and reproducible. Decided advantage is that the organic solvent is precluded but not at the expense of accuracy. The proposed method can be successfully employed in the routine analysis of Salicylic acid in drug sample. Hydrotropic analysis is a valuable technique for enhancing the solubility of poorly water-soluble drugs without the need for organic solvents or complex formulation. Hydrotropic analysis is a powerful approach for improving the solubility of poorly water-soluble pharmaceuticals without the need for chemical solvents or complex formulations.This technology increases drug dissolving, bioavailability, and analytical precision, making it a cost-effective and eco-friendly strategy in pharmaceutical research.The use of hydrotropic agents allows for the creation of accurate and reproducible analytical procedures for drug quantification, ensuring precision in quality control and formulation development.Overall, hydrotropic analysis adds greatly to modern pharmaceutical sciences by simplifying drug analysis and boosting therapeutic efficacy.Hydrotropy may find wide usage in creation of aqueous formulations of poorly water soluble pharmaceuticals in the future.
AKNOWLEDGEMENT:-
We are thankful to the staff of the YSPM, YTC, Satara for their valuable time and support. We also thankful to my mentor Dr. A.M. Bhagwat, HOD. Of Pharmaceutical Chemistry, YSPM, YTC, SATARA .Special thanks to Mr. Prasad patil sir (Assistant of chemistry laboratory). And my all FRIENDS.
REFERENCES
Prachi Katvate*, Dr. Avinash M. Bhagwat, Mansi Mane, Avantika Bhandugare, Titrimetric Analysis of Bulk Drug Salicylic Acid Using Hydrotropic Solubilization Method, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 5, 2903-2906. https://doi.org/10.5281/zenodo.15450243
10.5281/zenodo.15450243
