You are hereANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IRBESARTAN BY DERIVATIVE SPECTROSCOPY (FIRST ORDER)

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF IRBESARTAN BY DERIVATIVE SPECTROSCOPY (FIRST ORDER)


About Authors:
Gunjan Kalyani*1, Vishal S. Deshmukh1, Pranita Kashyap1, Yogesh Vaishnav1, Ram D. Bawankar
1Shri Rawatpura Sarkar Institute of Pharmacy,
Kumhari, Durg, Chhattisgarh
*kalyani.gunjan@yahoo.in

Abstract
Irbesartan is chemically 2-butyl-3-({4-[2-(2H-1,2,3,4-tetrazol-5-yl) phenyl] phenyl} methyl) -1,3-diazaspiro [4.4] non-1-en-4-one. Irbesartan is an Angiotensin II receptor antagonist effective in the treatment of   Hypertension.  It is also effective in the treatment of High blood pressure.  It is also effective when used alone or in combination with other drugs. Objective of the present study is to develop a simple, sensitive, accurate, precise and rapid first order derivative spectrophotometric method for the estimation of irbesartan in pure form. For the estimation of irbesartan, solvent system employed was 50% v/v aqueous ethanol and wavelength of detection (λdet) was 237 nm. The linearity was obtained in the range 8 – 18 µg/ml, with a regression coefficient, R2 = 1. The LOD & LOQ were found to be 0.5 µg/ml and 1.63 µg/ml respectively. Obtained results showed that there is minimum intra day and inter day variation. The developed method was validated and recovery studies were also carried out. Sample recovery using the above method was in good agreement with their respective labeled claims, thus suggesting the validity of the method and non-interference of formulation excipients in the estimation. First order derivative spectroscopy method is simple, rapid and reproducible and further it can be used for the analysis.

Reference Id: PHARMATUTOR-ART-1431

Introduction
Irbesartan is chemically 2-butyl-3-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl) -1,3-diazaspiro [4.4] non-1-en-4-one. Irbesartan is an Angiotensin II receptor antagonist effective in the treatment of   Hypertension1.  It is also effective in the treatment of High blood pressure1.  It is also effective when used alone or in combination with other drugs. Irbesartan is a nonpeptide tetrazole derivative and an angiotensin II antagonist that selectively blocks the binding of angiotensin II to the AT1 receptor. In the renin-angiotensin system, angiotensin I is converted by angiotensin-converting enzyme (ACE) to form angiotensin II. Angiotensin II stimulates the adrenal cortex to synthesize and secrete aldosterone, which decreases the excretion of sodium and increases the excretion of potassium. Angiotensin II also acts as a vasoconstrictor in vascular smooth muscle1. Irbesartan, by blocking the binding of angiotensin II to the AT1 receptor, promotes vasodilation and decreases the effects of aldosterone. The negative feedback regulation of angiotensin II on renin secretion is also inhibited, but the resulting rise in plasma renin concentrations and consequent rise in angiotensin II plasma concentrations do not counteract the blood pressure–lowering effect that occurs. The action of ARBs is different from ACE inhibitors, which block the conversion of angiotensin I to angiotensin II, meaning that the production of angiotensin II is not completely inhibited, as the hormone can be formed via other enzymes. Also, unlike ACE inhibitors, irbesartan and other ARBs do not interfere with response to bradykinins and substance P, which allows for the absence of adverse effects that are present in ACE inhibitors (eg. dry cough)1.


Fig. 1: structure of irbesartan

UV spectrophotometry is generally preferred especially by small-scale industries as the cost of the equipment is less and the maintenance problems are minimal. The method of analysis is based on measuring the absorption of a monochromatic light by colorless compounds in the near ultraviolet path of spectrum (190-380nm). The fundamental principle of operation of spectrophotometer covering UV region consists in that light of definite interval of wavelength passes through a cell with solvent and falls on to the photoelectric cell that transforms the radiant energy into electrical energy.

Literature review suggested several analytical methods that have been reported for the estimation of Irbesartan in bulk or pharmaceutical formulations include High Performance Liquid Chromatography, and UV-Visible Spectrophotometry. Literature review also revealed that there is no First order Derivative Spectroscopic method. The objective of the work was to develop simple, accurate, precise and economic first order derivative Spectroscopic method to estimate the candesartan in bulk. The method should be simple, accurate, precise, reproducible and statistically valid.

Thus, the objectives of project:
I.            To develop a simple, precise, accurate method, less time consuming & economical derivative spectroscopic method.
II.            Under derivative spectroscopy, the development of First Order
derivative Method.
III.            Validation of developed method using common parameters:
a)      Linearity
b)      Precision
c)      Accuracy
d)     Sensitivity
e)      Limit of Detection (LOD)
f)       Limit of Quantification (LOQ)

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