WELCOME

1. WELCOME

2. UV Spectrophotometric Method Development And Estimation of Bicalutamide in Pharmaceutical Dosage Form

3. Contents • Introduction • Aim & Objective • Drug Profile • Experimental Methods • Validation • Result & Discussion • Conclusion

4. Introduction • Quality Control (QC)is a system of routine technical activities, to measure, ensure and control the quality in a product or service . The basic goal of quality control is to ensure that the products, services or processes provided meet specific requirements and are dependable, satisfactory and physically sound. • Quality Control is the implementation of regular test procedures to satisfy consumer needs and to prevent drugs of lesser than claimed therapeutic value from entering into the market. • the analytical studies are important to find out the exact amount of active pharmaceutical ingredients present in the dosage form .

5. Analytical methods are developed according to ICH guidelinesQuality assurance is the process of verifying or determining whether products or services meet or exceed customer expectations. Quality assurance is a process-driven approach with specific steps to help define and attain goals. This process considers design, development, production and service.Quality assurance demonstrates that the drug is 'FIT FOR USE' and can satisfy its consumers by lessening its defects and improving its usability and performance.

6. Aim & Objective • The aim of our project is to develop UV Spectrophotometric method of Bicalutamide • Under this method our objective is to • find λmax • Find calibration curve • Validation & • Quantification • Through this project, an attempt is being made to develop and validate simple, sensitive methods which include spectrophotometry for quantitative monitoring of Bicalutamide in pure as well as pharmaceutical dosage forms.

7. Drug Profile • Bicalutamide is in a class of medications called nonsteroidal antiandrogens which works by blocking the effect of androgen (a male hormone), to stop the growth and spread of cancer (Prostate Cancer ). • Bicalutamide is a racemate and the (R)-enantiomer is primarily responsible for its anti-androgenic activity.

8. Molecular mass :430.373g/molPka :Approx 12Solubility : Practically insoluble in water, slightly soluble in chloroform, and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran.Bioavailability :well absorbedRoutes :Oral

9. Methodology UV SPECTROPHOTOMETRIC METHOD • Many molecules absorb ultravioletlight.Absorption methods based on ultraviolet (UV) radiation(200-400 nm) find wide spread application for the identification and determination of organic and inorganic species. • Absorbance is directly proportional to the path length, b, and the concentration, c, of the absorbing species. Beer's Law states that A = abc, where a is a constant of proportionality, called the absorptivity • By plotting absorbance, A, against concentration, a straight line will be obtained. This calibration line may then be used to determine unknown concentration of solutions of the same material after measurement of absorbance

10. The choice of solvent is governed by the solubility of the absorbing substance and by the absorption of the solvent at the given wavelength • The absorption of UV radiation corresponds to the excitation of outer electrons which involves transitions of π ,σ and n electrons. σ to σ* Transitions : Requires high energy and shorter wavelength πto π* Transitions :Requires low energy and longer wavelength

11. Experimental Methods • Instrument SYSTRONICS UV-VIS Double Beam Spectrophotometer 2201 • Methodology Adopted • Preparation of standard solution • study of spectral characteristics of Bicalutamide R.S in THF • Calibration curve of Bicalutamide R.S in THF by UV absorption method • Development of an analytical method using this calibration plot • Comparative study of commercially available dosage form with Bicalutamide R.S • Statistical evaluation of the calibration plot • stability profile • Validation of the method

12. Spectral characteristics of Bicalutamide R.S • Multiple wavelength analysis of Bicalutamide R.S from 400 - 190 nm, shows maximum absorption at 276nm. • ie. Λmax = 276nm

13. Calibration curve of Bicalutamide • Prepared 10 sets of dilutions. • Wavelength at 276nm was fixed. • Absorbance were found by using single wavelength analysis. • Calibration curve was plotted by taking Absorbance Vs Concentration

15. The data reveals that Beer's law is obeyed between concentration range of 5-30 ug/ml. Above 45 ug/ml the absorbance value was found to be very high

16. Y = 0.042286X + 0.11 Correlation coefficient =0.999 standard deviation =0.39502 standard error was 0.01465

17. Validation of the proposed method • Accuracy • Repeatability • LOD and LOQ • Linearity • Range

18. Accuracy • It expresses the closeness of agreement between reference value and value found . • Accuracy was evaluated by carrying out a recovery study. • And the method was found to be accurate.

19. Repeatability • Repeatability expresses the precision under same operating conditions over a short interval of time. • It is usually expressed as the closeness of agreement between a series of measurements obtained. • It is usually expressed as the standard deviation, variance, or relative standard deviation of a series of measurements.

20. LOD and LOQ • The limit of detection (LOD) is defined as the lowest concentration of an analyte that can be detected. • But not necessarily quantified as an exact value. • LOD = 3s/m • And was found to be 2µg/ml.

21. The limit of quantification (LOQ) is defined as the lowest concentration of the standard curve that can be measured with an acceptable accuracy, precision, and variability. LOQ = 10s/m And was found to be 7µg/ml

22. Linearity • The linearity of an analytical procedure is its ability to obtain test results, which are directly proportional to the concentration of the analyte in the sample. • The calibration curve of Bicalutamide by the proposed method was found to be linear over the range of 5-30 µg/ml