METHOD DEVELOPMENT AND ITS VALIDATION FOR ESTIMATION OF SPIRONOLACTONE IN TABLET DOSAGE FORM BY UV SPECTROPHOTOMETRY

About Author:
Kapil Sharma^1*, Yogesh Sharma², Anju Goyal^1
1B. N. College of Pharmacy
Udaipur - 313002, Rajasthan, India.
²Yaresun Pharmaceuticals Pvt. Ltd.,
Jaipur - 302006, Rajasthan, India.

Abstract
This paper describe a simple, precise and economical spectrophotometric method for the quantitative determination of spironolactone (SPL) in tablet dosage form. Method is based on the estimation of SPL in 50 % v/v methanol in distilled water at 238 nm. Beer’s law was obeyed in the concentration range of 2-24 µg/ml. The accuracy of the method was assessed by recovery studies and was found to be 100.55±1.27 for SPL. Results of the analysis were validated statistically so that it can be used for routine analysis of SPL in tablet dosage form.

REFERENCE ID: PHARMATUTOR-ART-1139

Introduction
Spironolactone is chemically (7α, 17α)-7-(Acetylthio)-17-hydroxyl-3-oxopregn-4-ene-21-carboxylicacid-γ-lactone and used as diuretic.  Spironolactone acts from the interstitial side of the tubular cell combines with the mineralocorticoids receptor and inhibits the formation of aldosterone induced proteins (AIPs) in a competitive manner¹.  It is official in I.P² and USP³.  Literature survey reveals that two quantitative spectrophotometric method^4-5 and two HPLC^6-7 methods are reported for the determination of SPL. Hence the objective of the work is to develop new spectrophotometric method for its estimation in tablet dosage form with good accuracy, simplicity, precision and economy. The result of analysis using the spectrometric method for quantitative determination was found to be satisfactory such that the developed method can be used for routine analysis of drug from tablet dosage form.

Material & Method
Instrument, reagents and chemicals
A dual-beam shimadzu UV-visible spectrophotometer 1601 was used. Freshly prepared 50 % v/v methanol (LR, Merck, mumbai) in distilled water was used as solvent. Gift sample of SPL was procured from Micro labs ltd, Bangalore. Tablets of 50 mg strength were procured from local pharmacy of Aldactone brand (RPG life sciences, HP).

Stock solution
Stock solution of containing 500 µg/ml of spironolactone was prepared by dissolving 25 mg spironolactone in 50 ml 50 % v/v methanol in distilled water.

Standard solution
Standard solution of containing 10 µg/ml was prepared by dissolving 5 ml spironolactone stock solution in 50 ml 50 % v/v methanol in distilled water. Standard solution was analyzed by UV-spectrophotometer. Maximum absorbance for spironolactone was found to be at 238 nm. The spectrum was shown in figure 1.

Linearity and accuracy
Linearity and accuracy in the concentration range of 2-24 µg/ml were examined employing intraday and interday studies for the determination of SP. The results for intraday and interday experiments with a good correlation were obtained and evaluated statistically as demonstrated in table 1 and 2.calibration curve is shown in figure 2.

Application of proposed procedure for the determination of spironolactone in tablet dosage form

Twenty tablets were taken, and accurately weighed. The tablets were crushed to a fine powder. The powder sample equivalent to 50 mg of spironolactone was transferred to a 100 ml volumetric flask and about 80 ml of 50 % v/v methanol in distilled water was added and sonicated to dissolve. The volume was made up to the mark with 50 % v/v methanol in distilled water. This solution was filtered through whatman filter paper 42. 10 ml of this solution was diluted to 100 ml with 50 % v/v methanol in distilled water. The solutions were analyzed by UV-spectrophotometer. 50 % v/v methanol in distilled water  was used as blank.

RESULTS AND DISCUSSIONS
A UV-spectrophotometric method was developed for the estimation of spironolactone in tablet dosage form were found to be simple, accurate, precise and reproducible. Method is based on the estimation of spironolactone in 50 % v/v methanol in distilled water at 238 nm. Beer’s law was obeyed in the concentration range of 2-24µg/ml. The value of standard deviation was satisfactory and the recovery studies were close to 100%.Hence this method can be used in the routine analysis of spironolactone in tablet dosage form.

ACKNOWLEDGEMENTS
The authors are thankful to principal of B.N. College of Pharmacy, Udaipur for his constant support and vice president of Yaresun pharmaceuticals p. ltd, jaipur for providing the facilities to carry out the work. The authors are also thankful to Yaresun labs, Jaipur for providing working standard of spironolactone.

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REFERENCES
1. K.D.Tripathi, Essential Medical Pharmacology, 5th edition, Jaypee Brothers, New Delhi, 2004;P. 525 & 537.
2. Indian Pharmacopoeia, 4th ed, New Delhi India, the controller of publications: 1996: Vol-II:709-710.
3. United states pharmacopoeia, 28^th ed, Washington, Published by the board of trustees, 2005:Vol-II: 1953.
4. Dinc Erdal, Ustunda Ozgur. Spectrophotometric quantitative resolution of hydrochlorothiazide and spironolactone in tablets by chemometric analysis method. II Farmaco 2003; 58:1151-61.
5. Martin E, Jimenez AI, Hernandez O, Jimenez F,Arias JJ. Simultaneous kinetic spectrometric determination of spironolactone and canrenone in urine using partial least-square regression.Talanta 1999; 49:143-54.
6. De Croo F, Bossche W. vanden, Moerloose P.de. Simultaneous determination of spironolactone and althiazide in tablets by high-performance liquid chromatography. Fresenius’ Journal of Analytical chemistry 2004; 323:91-93.
7. Kenneth S. Alexander, Shyam Sunder K.S. Vangala, David Dollimore. Improved High-performance liquid Chromatography Assay for spironolactone analysis.Drug development and industrial pharmacy 1998; 24:101-7.

Table 1: Recovery study of spironolactone

Table 2: Summary of validation parameters

Figure1:Absorvance of Spironolactone

Figure 2: Calibration curve of spironolactone

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