New first derivative spectrophotometric methods for the estimation of Bumetanide in tablet dosage forms

 

Mukthinuthalapati Mathrusri Annapurna*, Avuthu Sai Sheela, Rangisetty Spandana Yasaswini

Department of Pharmaceutical Analysis & Quality Assurance, Gandhi Institute of Technology and Management, GITAM Institute of Pharmacy, GITAM (Deemed to be University),

Visakhapatnam, Andhra Pradesh-530045, India.

 

ABSTRACT:

First derivative spectrophotometric methods have been developed for the assay of Bumetanide using Shimadzu UV-1800 Model double beam UV-VIS spectrophotometer in reagents such as hydrochloric acid, phosphate buffer pH 3.6, phosphate buffer pH 2.0 and distilled water. Bumetanide has shown linearity 10-70 µg/ml in all the methods and the linear regression equations are found to be y = 0.0015x - 0.0013 (R² = 0.9993), y= 0.0007x - 0.0004 (R² = 0.9991), y = 0.0014x - 0.0015 (R² = 0.9993) and y = 0.0014x - 0.0015  (R² = 0.9995) in hydrochloric acid, phosphate buffer pH 3.6, phosphate buffer pH 2.0, and distilled water respectively. The methods are validated as per ICH guidelines and found to be precise, simple and accurate.

 

 

 

INTRODUCTION:

Bumetanide (Figure 1) is used to reduce extra fluid in the body¹. Chemically, Bumetanide is 3-(butyl amino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42. Various analytical techniques were developed for the estimation of Bumetanide such as HPLC with fluorimetric detection^2-4, UV detection^5-6, amperometric detection⁷, UPLC⁸, UFLC⁹, LC-ESI-MS/MS¹⁰, HPTLC¹¹ and spectrophotometry^12-13 and in the present study the authors have proposed four different first order derivative spectrophotometric methods in hydrochloric acid, phosphate buffer pH 3.6, phosphate buffer pH 2.0 and distilled water.

 

 

Figure 1: Chemical structure of Bumetanide

 

MATERIALS AND METHODS:

Bumetanide is available as tables with brand names Burinex (Labelled claim: 2 mg/mL) (Leo pharma), Bumex (Validus pharmaceuticals LLC) (Genentech, Inc.) (Labelled claim: 1 and 0.5 mg). Model No. UV-1800 double beam UV-VIS spectrophotometer (Shimadzu) with quartz cells is used for the study and the solutions were scanned (200-400 nm). 

 

Preparation of solutions

Solutions such as phosphate pH 3.6, phosphate pH 2.0 and 0.1 N hydrochloric acid were prepared as per IP 2010. Stock solution of Bumetanide was prepared by dissolving 25 mg of Bumetanide in 25 ml volumetric flask with methanol (1000 µg/ml) and further working standard solutions (100 µg/ml) were prepared by diluting the stock solution with 0.1 N hydrochloric acid, phosphate pH 3.6, phosphate pH 2.0 and distilled water for Method A, B, C and D respectively. Bumetanide tablets of two different brands were procured and extracted with methanol followed by dilutions and assay was performed.

 

Method validation

Linearity

A series of Bumetanide solutions 10-70 µg/ml were prepared in 0.1 N hydrochloric acid, phosphate buffer pH 3.6, phosphate buffer pH 2.0 and distilled water from the stock solution and scanned (200-400 nm) against their reagent blanks. The absorption spectrum so obtained was transformed in to first order derivative spectra with the help of inbuilt software in the instrument and the resultant derivative spectra has shown maxima and minima and therefore the amplitude was chosen for the calculation purpose. In the first method the derivative spectrum observed in 0.1N HCl (Method A) has shown maxima at 262 nm and minima at 280.68 nm and therefore amplitude (262-280.68 nm) was chosen against concentration for all calculations to build the calibration curve. Similarly, amplitude 314.77-353.46, 222.53-241.76 and 220.33-242.58 nm were chosen phosphate buffer pH 3.6, phosphate buffer pH 2.0 and distilled water for Method B, C and D respectively.

 

Precision and accuracy studies

The intra-day and inter-day precision studies were executed at three different concentration levels (10, 20 and 30 µg/ml) and accuracy studies were carried out by standard addition method (50%, 100%, and 150%). The % recovery was calculated for all techniques Method A, B, C and D.

 

Assay of Bumetanide tablets

Twenty Bumetanide tablets were weighed accurately, powdered and powder equivalent to 25 mg of Bumetanide was extracted with methanol in a 25 ml volumetric flask and dilutions were made using 0.1 N hydrochloric acid, Phosphate buffer pH 3.6, Phosphate buffer pH 2.0 and distilled water for Method B, C and D respectively. The assay was carried out using the above analytical techniques and the percentage recovery was calculated.

 

RESULTS AND DISCUSSION:

Four new spectrophotometric methods have been developed for the assay of Bumetanide tablets. The previously published analytical methods in the literature were compared with the present proposed methods in Table 1.

 

Table 1: Comparison of published methods with the present method

 

The first order derivative absorption spectra so obtained 0.1 N hydrochloric acid, Phosphate buffer pH 3.6, Phosphate buffer pH 2.0 and distilled water for Method B, C and D respectively was shown in Figure 2. The calibration curves for Method A, B, C and D were shown in Figure 3. Beer-Lambert’s law was obeyed over the concentration range 10-70 µg/ml in Method A, B, C and D (Table 2) and the linear regression equations were found to be y = 0.0015x - 0.0013 (R² = 0.9993), y= 0.0007x - 0.0004 (R² = 0.9991), y = 0.0014x - 0.0015 (R² = 0.9993) and y = 0.0014x - 0.0015 (R² = 0.9995) in hydrochloric acid, phosphate buffer pH 3.6, phosphate buffer pH 2.0 and distilled water for Method B, C and D respectively. The percentage RSD in precision and accuracy studies was found to be less than 2 indicating that the methods are precise (Table 3) and accurate (Table 4). The characteristics and the assay results of Bumetanide for all the four methods were given in Table 5.

 

Method A (0.1N HCl)	Method B (Phosphate buffer pH 3.6)
Method C (Phosphate buffer pH 2.0)	Method D (Distilled water)
Figure 3: Calibration curves of Bumetanide (First order derivative spectroscopy)

 

 

Table 2: Linearity of Bumetanide (First order derivative spectroscopy)

 

Table 3: Precision study of Bumetanide (First order derivative spectroscopy)

 

Table 4: Accuracy study of Bumetanide (First order derivative spectroscopy)

 

Table 5: Characteristic parameters of Bumetanide (First order spectroscopy)

 

Method A (0.1N HCl)	Method B (Phosphate buffer pH 3.6)
Method C (Phosphate buffer pH 2.0)	Method D (Distilled water)
Figure 2: Overlay first derivative spectra of Bumetanide

 

CONCLUSION:

The four first order derivative spectrophotometric methods are found to be simple, economical, precise and accurate for the routine analysis of Bumetanide tablets.

 

ACKNOWLEDGEMENT:

The authors are grateful to M/s GITAM (Deemed to be University), Visakhapatnam for providing the research facilities Leo pharma (India) for supplying gift samples of Bumetanide. The authors declare no conflict of interest.

 

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Accepted on 10.10.2019           © RJPT All right reserved

Research J. Pharm. and Tech 2019; 12(10):4790-4794.