Validated Uv Spectrophotometric Quantification of Dutasteride In Pharmaceutical Formulations by Using Multivariate Technique

S. Yuvasri; B. Dhatchinamoorthy; G. Dhivagar; N. Dravid vishal; A. Ganesh; N. Gokulakrishan

doi:10.5281/zenodo.14983796

Research Paper | Open Access
Volume 02 | Issue 03 | Article Id IJSRT/250303003

Validated Uv Spectrophotometric Quantification of Dutasteride In Pharmaceutical Formulations by Using Multivariate Technique
S. Yuvasri* B. Dhatchinamoorthy G. Dhivagar N. Dravid vishal A. Ganesh N. Gokulakrishan
Aadhibhagawan College of Pharmacy, Rantham, Vembakkam - 604407. Tamil Nadu, India

Abstract

The Present work focuses an accurate, simple and precise UV method with multivariate calibration technique for the estimation of Dutasteride in pharmaceutical dosage form. Multivariate calibration method uses the linear regression equations by correlating the relation between concentration and absorbance at 5 different wavelengths. The ?maxof Dutasteride shows at 269 nm and obeyed Beers law in the range of 1-5?g/ml. The percentage recovery of tablet formulation was found to be in the range of 98.50 to 99.88%. The limit of quantification and limit of detection were found to be 1.272 and 0.0420?g/ml respectively. The low percentage RSD values are indicated the accuracy and precise of the method. The present method can be successfully applied for method development and validation by multivariate analysis of Dutasteride.

Keywords

Dutasteride, ?max, Development, Validation, Multivariate Technique

Introduction

Dutasteride is an aza-steroid that is inasteride in which the tert-butyl group is replaced by a 2,5- bis (trifluoromethyl)phenyl group. A synthetic 4-azasteroid, dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5alpha-reductase, an intracellular enzyme that converts testosterone to 5alpha-dihydrotestosterone. Dutasteride is used for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate gland. It has a role as an EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP (+))] inhibitor and an anti-hyperplasia drug. It is an aza-steroid, a member of (trifluoromethyl)benzenes and a delta- lactam. It derives from a hydride of a 5 alpha-androstane. Benign Prostatic Hyperplasia Is Currently Treated with The Drug Dutasteride. Similar to The Finasteride, nearly 50 % Of Serum Prostate Specific Antigen Is Reduced At The Period Of 6 Months and Having a 25 % Of Prostate Volume In 2 Years. Dutasteride Is a Competitive and Specific Inhibitor Of Both Type I and Type II 5α-Reductase Isoenzymes and When Evaluated Under In-Vitro and In-Vivo Conditions, The Dissociation Of The Drug From The Drug-Enzyme Complex Is Reported To Be Extremely Slow. Dutasteride Does Not Bind to The Human Androgen Receptor. Multivariate Calibration Refers to The Process of Constructing a Mathematical Model That Relates a Property Such as Content Or Identity To The Absorbance Of a Set Of Known Reference Samples At More Than One Wavelength. If the Absorbance of An Analyte (z) Is Measured At Five Wavelength Set, Straight Line Equation Can Be Written As; Aλ= Ax (Cz+k) Where A λ Represent The Absorbance Of The Analyte, a Is The Slope and k is The Intercept Of The Linear Regression Function Of The Analyte. Cz Represents the Concentration Of Analyte. At Five Selected Wavelengths, The Equation System Can Also Be Summed As; At= Ax(Cz+b)x(Cz+c)x(Cz+d)x(Cz+e)x(Cz+Kt),

Which Can be Simplified To At=Cz (a+b+c+d+e)+K tWhere a,b,c,d,e are The Slopes, At And KtRepresents The Sum Of Absorbance Obtained And Sum Of Intercepts Of Regression Equation At Five Wavelength Set Respectively .The Concentration Of The z Analyte In a Mixture Can be Calculated By Given Equation Cz = At–Kt/(a+b+c+d+e) .The Present Research Work Focuses On The Application Of Uv Spectral Multivariate Calibration Technique Having Simple Mathematical Content For The Quantitative Determination Of Dutasteride In Pharmaceutical Formulation.

Drug Profile:

Drug Name: Dutasteride

Chemical Name: N- [2,5-bis (trifluoromethyl) phenyl] -3-oxo-4-aza- 5α-androst- 1-ene- 17β- carboxamide

Molecular formula: C27H30F6N2O2

Molecular Weight: 528.5 g/mol

Strength: 0.5mg

Appearance: A white to pale yellow powder.

Solubility: That is soluble inorganic solvents but not in water.

Melting point: 242°to250°C.

Boiling point: 620.3°Cat760 mmHg

Bioavailability: The oral bioavailability of dutasteride is about 60%.

Elimination Half-Life: About 4 to 5 weeks..