New Spectrophotometric Gliclazide Determination in Tablets Formulations by Charge Transfer Complexation

 

Saad Aantakli, Leon Nejem, Monzer ALraii

Department of Chemistry, Faculty of Sciences, University of Aleppo, Syria.

*Corresponding Author E-mail: antakli@scs-net.org, leonnejem@ gmail.com, monzersalah701@gmail.com

 

ABSTRACT:

Rapid useful and easy spectrophotometric method for quantitative analysis of Gliclazide(GLZ)in raw material and tablets pharmaceutical formulation has been described. This method is based on the formation of yellow ion-pair complex between (GLZ) and Bromocresol purple (BCP) in Toluene medium. Different parameters affecting the reaction such as: effect of solvents, time, reagent concentration, correlation ratio, etc. were optimized. The absorbance of the formed complex GLZ-BCP was measured by visible spectrum at absorption maximum 415 nm. The range of linearity was(4.85 – 113.19) µg/mL,regression analysis had a good correlation coefficient R2 = 0.9999. The limit of detection (LOD)and limit of quantification (LOQ)were to be 0.47µg/mL and 1.44µg/mL respectively. The average percent recovery of (GLZ) was found to be (99.73 – 100.41)%. The method was successfully applied for the determination of (GLZ) in tablets pharmaceutical formulations in Syrian pharmaceutical products: UNICRON. The proposed method is simple, direct, and sensitiveand does not require any pre-extractionprocess. Thus, the method could be ready to apply in routine analysis and quality control.

 

KEYWORDS: Gliclazide (GLZ), Bromocresol purple (BCP), Spectrophotometry.

 

 


INTRODUCTION: 

Gliclazide (Hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(4-methylphenyl) sulfonyl]urea1, is an oral hypoglycemic drug, belong to second-generation sulphonylureas, used in type-IIDiabetes. (GLZ) may reverse insulin resistance in type-II diabetic patients and improves defective insulin secretion. It is readily absorbed from the gastro-intestinal tract2. The estimation of (GLZ) in pharmaceutical formulations has been determining by several analytical methods. These include UV Spectroscopy methods3-13, Spectrofluorimetric method14, Fourier trans form infrared (FTIR) Spectrophotometric15, Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) methods16-21 and High Performance Liquid Chromatography (HPLC)22-24, Liquid Chromatography (LC)25, Liquid Chromatography–Mass Spectrometry (LC-MS)26, Gas Chromatography (GC)27, High Performance Thin Layer Chromatography (HPTLC)28 and Thin Layer Chromatography (TLC)29.

 

 

MATERIALS AND METHODS:

Apparatus:

All spectral measurements were carried out using a SpectorScan (Jasco V-630 UV–VIS) spectrophotometer (Japan) with 1cm quartz cells, Ultrasonic bath Daihan (China), Stirrer Velp Scientifica (Europe), and Sartorius balance sensitivity 10-5g.

 

Chemical regents:

Gliclazide (GLZ): C15H21N3O3S Mw = 323.4g/mol from (China), its purity 100%. Bromocresol purple (BCP): C21H16Br2O5S, Mw = 540.22g/mol from Merck (Germany). Methanol from Merck (Germany). Toluene from Eurolab (UK).

 

Standard Preparation:

(GLZ) stock solution:

Stock solution 2 × 10-3 M of (GLZ),Mw = 323.4 g/mol was prepared by dissolving 32.34 mg of raw material in volumetric flask 50mL with 10mL Methanol and completed to volume with Toluene to give concentration 2 × 10-3 M equivalent to 646.8𝜇g/mL. Prepared working standard solutions of (GLZ)by appropriate dilutions among (75 - 1750)𝜇L of 646.8𝜇g/mL solution in volumetric flasks 10mL and added to each one of (BCP)1 × 10-2M equals to five timesof (GLZ)concentration, then completed to volume with Toluene to give concentrations (4.85 – 113.19) 𝜇g/mL of (GLZ).

 

Reagent stock solution:

Bromocresol purple 1 × 10-2 M was prepared by dissolving 270.11mg of (BCP), Mw = 540.22g/molin volumetric flask 50 mL and completing to volume withToluene.

 

Calibration Curve:

To construct the calibration curve, for each concentration five standard solutions were prepared and measured the absorbance five times for each solution.

 

Sample preparation:

Three Syrian products were studied:

·       Twenty tablets from UNICRON (GLZ) 80mg were weighed and finely powdered and an accurate weight equivalent to 80mg (GLZ) was accurately weighed, dissolved in volumetric flask 10mL of Methanol, then has been taken 0.5mL of the solution to volumetric flask 10mL and diluted to volume with Toluene. 1mL of the last solution transferred to 10mL volumetric flask and added 1.75mL of (BCP)1× 10-2 M, then diluted to volume with Toluene to obtained theoreticallyconcentration equivalent to 40.0𝜇g/mL of (GLZ).

·       Twenty tablets from UNICRON (GLZ) 60 mgwere weighed and finely powdered and an accurate weight equivalent to 60mg (GLZ) was accurately weighed, dissolved in volumetric flask 10mL of Methanol, then has been taken 0.7mL of the solution to volumetric flask 10 mL and diluted to volume with Toluene.1 mL of the last solution transferred to 10 mL volumetric flask and added 1.75mL of (BCP)1× 10-2 M, then diluted to volume with Toluene to obtained theoretically concentration equivalent to 42.0𝜇g/mL of (GLZ).

·       Twenty tablets from UNICRON (GLZ) 30 mgwere weighed and finely powdered and an accurate weight equivalent to 30mg (GLZ) was accurately weighed, dissolved in volumetric flask 10mL of Methanol, then has been taken 1mL of the solution to volumetric flask 10mL and diluted to volume with Toluene.1 mL of the last solution transferred to 10 mL volumetric flask and added 1.75mL of (BCP)1× 10-2 M, then diluted to volume with Toluene to obtained theoretically concentration equivalent to 30.0𝜇g/mL of (GLZ).

 

RESULTS:

(GLZ) forms with (BCP) at 25±5şC a yellow ion-pair complex.The formed complex spectrum was scanned between the 300 - 550nm against a blank of(BCP) solved in Toluene.The absorbance maximum wavelength wasat 415nm. the parameters were studied of the result colored complex solutions to obtain the optimal conditions.
 
DISCUSSION:
This method depends on the study of color ion-pair complex between the (GLZ) and (BCP). It gives lowest linearity range comparing with others spectrophotometric studies, but more sensitive than the others works. The results showed good results for percentage of recovery, accuracy and precision.
 
Figure 1 shows the complex spectrum between (GLZ) and (BCP)in Toluene medium.
 

Figure 1: a- Spectrum of complex (GLZ)-(BCP) in Toluene medium, [GLZ] = 1 × 10-4 M, b- Spectrum of (BCP) in Toluene medium, [BCP] = 5 × 10-4 M.

 

Stability of stock solution:

Time effect on stability standard stock solution of (GLZ) in Methanol was studied in three different concentrations (1× 10-4, 1,5× 10-4, 2× 10-4) M. We did not notice any significant absorption changes within two months.

 

Effect of reagent concentration:

To study the effect of reagent concentration on the colored complex solution (GLZ)-(BCP), has been  made a series of 10mL of separated volumetric flasks, by adding 1mL of (GLZ)1 × 10-3 M  equivalent to 100µM and added between (0.025 – 1.1) mL of (BCP) 1 × 10-2 M, equivalent to (25 – 1100)µM after completing the volume to 10mL by Toluene. The absorbance at 415nm for each one of (BCP) reagent was measured against the blank of Toluene. It was found that the completed colored complex formation in the best condition was 500µM of (BCP) equivalent to 0.5mL of (BCP), which equal to five times of (GLZ) concentration, as it is shown in figure2.

 

 

Figure 2: Effect of reagent concentration. [GLZ]100 µM.

 
Correlation ratios by molecular ratio:
We have prepared a series of complex solutions (GLZ)-(BCP) in Toluene medium. The concentration of the (BCP) reagent changes within the ratio (4.534.5)×10-5 M while the concentration of (GLZ) was constant in each solution and equal to 2 × 10-3 M. We havemeasured the absorbance values of these solutions at the wavelength of the maximum absorbance 415 nm (using Toluene as a blank). The absorption changes of the molecular ratio of the reagent to the (GLZ)permitted to measure correlation ratio. We obtained the curve A = f ([(BCP)]/[GLZ]) shown infigure 3 where the correlation ratios are (1:1).
 
 
Figure 3: Correlation molecular ratios (1:1).
 

Correlation ratios by continuous variation:

We have prepared a series of complex solutions (GLZ)-(BCP) in the medium of the Toluene. The concentration of the reagent and the concentration of (GLZ) changes in solutions between (0.3 3)× 10-4 M where the sum of both concentrations remains constant and equal to 3 × 10-4 M. 
 
We measured the absorbance values of these solutions at the wavelength of the maximum absorbance 415 nm according to the used reagent percentage of the formed complex in terms of molecular fraction of (GLZ). We obtained the curve A = f([(BCP)]/{[(BCP)] + [GLZ]}), shown in figure 4, where the correlation ratios are (1:1).
 
Figure 4: Correlation ratio by continuous variation (1:1).
 

Calculation of formation constantfor the (GLZ)-(BCP)complex:

We calculated the conditional stability constants (𝐾𝑓) of the ion-pair complexes(GLZ)-(BCP) from molecular ratio and the continuous variation curves.Data using the following equation30,31.

 

 

Where 𝐴 and 𝐴𝑚 are the absorbance values and the observed maximum absorbance value when all the (GLZ)is completely associated with Bromocresol purple, respectively. 𝐶𝑀 is the mole concentration of (GLZ) at the maximum absorbance and 𝑛 is the stoichiometry, where dye ion associates with (GLZ). The log 𝐾𝑓 values for (GLZ)-(BCP) ion-pair, associated at correlation ratio (1:1) by molecular ratio was8.07, and by continuous variation was 8.00, so log𝐾𝑓 average was 8.035.

 

METHOD’S VALIDATION:

The validity and suitability of the proposed method was assessed by linearity evaluated by regression equation, Limit of Detection (LOD), Limit of Quantification (LOQ), accuracy reported as percent %, precision reported as RSD %, robustness, and Sandall's sensitivity.

 

Linearity:

We studied the linearity of (GLZ) concentrations at the optimal conditions we made a series of 10mL of separated volumetric flasks, each one contains concentration of (BCP) equals to five times of(GLZ) concentration, where the variable concentrations of (GLZ) stock solution 2×10-3 M and the concentration of (BCP) stock solution 1 ×10-2M, then the volumetric flasks  completed to 10mL with Toluene, finally we measured the absorbance at 415nm for each concentration against the blank of (BCP) in Toluene. Figure 5 presents the complex of (GLZ) - (BCP) spectra. The range of linearity obeyed to Beer’s Law in concentration (4.85 – 113.19) μg/mL and the linearity curve is presented in Figure 6.

Figure 5: Spectra of (GLZ)-(BCP) complex for different concentration of (GLZ):

C1: 4.85 𝜇g/mL, C2: 8.09 𝜇g/mL,

C3: 16.17 𝜇g/mL, C4:32.34 𝜇g/mL,

C5: 48.51 𝜇g/mL, C6: 64.68 𝜇g/mL,

C7: 80.85 𝜇g/mL, C8: 97.02 𝜇g/mL,

C9: 113.19 𝜇g/mL.

n = 5 for each concentration.

 

 

 

 

Figure 6: Spectra of (GLZ)-(BCP) complex for different concentration of (GLZ):

C1: 4.85 𝜇g/mL, C2: 8.09 𝜇g/mL,

C3: 16.17 𝜇g/mL, C4:32.34 𝜇g/mL,

C5: 48.51 𝜇g/mL, C6: 64.68 𝜇g/mL,

C7: 80.85 𝜇g/mL, C8: 97.02 𝜇g/mL,

C9: 113.19 𝜇g/mL.

n = 5 for each concentration.

 

 

 

Limit of detection (LOD) and limit of quantification (LOQ):

In spite of the measurement (LOD) and (LOQ), five concentrations calculated in five replicates.

(LOD) and (LOQ) for (GLZ) by using the following equations:

               3.3xSD                      10xSD

LOD = ----------          LOQ = ------------    (2)        

                y                                 y

Where SD: is the standard deviation of y intercepts of regression lines and m is the slope of the calibration curve. (LOD) and (LOQ) were to be 0.47𝜇g/mL and 1.44𝜇g/mL respectively.

 

Accuracy:

To determine the accuracy and precision of the proposed method, five replicates determinations has been carriedout on five different concentrations of standards (GLZ).The validation results waspresented in table 1.

 

Precision:

In order to demonstrate the precision of the proposed method, Intra-day and Inter-day variability studies performed at three different concentrations (48.51, 64.68, and 80.85) 𝜇g/mL for (GLZ) at the same day in two hours' time interval and at three days. Method efficiency was tested in terms of RSD% for both intra-day and inter-day precisions.

 

Accuracy confirmed by making five replications of standard (GLZ) under study and the mean was calculated. The results were presented in Table 2. The RSD% results didn't exceed more than 1.83 % during the determination in one day or three days, where the method is considered precise.

 


Table 1: Precision and accuracy for determination of (GLZ).

Theoretical concentration (μg/mL)

 Observed concentration (μg/mL)

SD

(µg/mL)

Precision

RSD (%)

Accuracy (%)

LC = ± [t .SD/(n)˝]

(µg/mL)

4.85

4.96

0.18

3.63

102.27

4.96 ± 0.224

32.34

32.39

0.40

1.23

100.15

32.39 ± 0.497

64.68

64.46

0.31

0.48

99.66

64.46 ± 0.385

97.02

97.24

0.28

0.29

100.23

97.24 ± 0.348

113.19

113.69

0.66

0.58

100.44

113.69 ± 0.821

: mean of five replicated determinations,

Accuracy (%) = (observed concentration/ theoretical concentration) x 100,

Precision (RSD %) = (standard deviation/ mean concentration) x 100.

LC: Limit of confidence at 95 %; t = 2.78.



Table 2:  Intra-day and inter-day precision for determination of (GLZ).

Concentration

Found concentration μg/mL

𝜇g/mL

* Time I

Precision

* Time II

Precision

* Time III

Precision

 

RSD %

RSD %

RSD %

48.51

48.55

0.29

48.75

0.16

48.56

0.58

64.68

64.55

0.39

64.58

0.55

64.34

0.54

80.85

80.87

0.25

80.9

0.39

80.77

0.21

Concentration

Found Concentration μg/mL

𝜇g/mL

* Day I

Precision

*Day II

Precision

*Day III

Precision

 

RSD %

RSD %

RSD %

48.51

48.55

0.29

48.56

0.62

48.52

0.96

64.68

64.55

0.39

64.47

0.76

64.64

0.69

80.85

80.87

0.25

80.63

1.83

80.87

1.04

*n = 5.

 

Table 3: Robustness test.

Parameter

Deviation

(µg/

mL)

SD

(µg/

mL)

RSD%

Per

%

(µg/

mL)

SD

(µg/

mL)

RSD%

Per

%

(µg/

mL)

SD

(µg/

mL)

RSD%

per

%

Slit rang

(1 nm)

2 nm

1 nm

32.35

32.33

0.15

0.42

0.47

1.30

100.

03

99.97

48.68

48.52

0.17

0.14

0.35

0.29

100.

35

100.

02

64.58

64.69

0.43

0.09

0.67

0.14

100.

00

100.

17

Scan speed

(Fast)

Fast

Slow

32.3332.26

0.42

0.15

1.30

0.46

99.97

99.75

48.52

48.29

0.14

0.83

0.291.72

100.0299.55

64.6964.45

0.09

0.56

0.140.87

100.

17

99.80

Wave length

+2 nm

- 2 nm

32.22

32.15

0.25

0.39

0.78

1.21

99.63

99.41

48.47

48.62

0.13

0.28

0.27

0.58

99.92

100.

23

64.51

64.37

0.53

0.62

0.82

0.96

99.89

99.67

*n = 5.

 

Table 4: Recoveries of (GLZ) in UNICRON products.

Pharmaceutical dosage

Sample

Added

Total Found

Recovery  Average

SD*

RSD* %

Recovery

µg/mL

µg/mL

  µg/mL

%

µg/mL

Average %

(GLZ)

30 mg/tab.

 

29.92

23.94

53.71

99.37

1.16

1.17

100.41

29.92

59.89

100.17

1.36

1.36

35.9

66.43

101.7

0.67

0.66

(GLZ)

60 mg/tab.

 

41.98

33.58

75.34

99.34

1.48

1.49

99.73

41.98

83.8

99.62

2.19

2.2

50.38

92.47

100.22

1.22

1.22

(GLZ)

80 mg/tab.

 

39.99

31.99

71.92

99.81

0.86

0.86

99.88

39.99

79.88

99.75

1.08

1.08

47.99

88.02

100.08

0.74

0.74

* Mean for five replicates, *calculated from recovery.

 


Robustness:

The robustness of an analytical procedure is a measurement of its capacity to maintain unaffected results by a very small variation of some parameters and provides an indication of its reliability during normal usage. The studied variables parameters were slit, scan speed and the wavelength which performed at three different concentrations (32.34, 48.51 and 64.58) µg/mL for (GLZ). The obtained results in Table 3 showed no significant differences.

 

Sandell’s Sensitivity and molar absorptivity ε:

Sensitivity of the proposed method for (GLZ) was determined by calculating Sandell’s sensitivity (SS), it was to be SS = 0.085µg/cm2. The mean molar absorptivity ε was found equal to 7616.03L/mol.cm.

 

RECOVERY:

The recovery studied by three addition standards (80%, 100%, and 120%) for every doses.Table 4 presents the recoveries results for the three Syrian pharmaceutical products UNICRON.

 

 

APPLICATION:

The method was applied for quantitative determination of (GLZ) in three Syrian pharmaceutical tablets products UNICRON for five different batches for each one. The samples were prepared as mention before in the section of samples preparation and analyzed. Quantitative analysis was done by using calibration curve. The obtained results are summarized in Table 5. In general, the concentrations of the detected (GLZ) in each product was within the allowed limits under British Pharmacopoeia(BP) legislation1, The tablets must contain not less than 95 % and not more than 105% of labeled amount,so the obtained results are conformed to BP legislation1.

 


 

Table 5: Results of(GLZ) in UNICRON doses tablets.

Product

UNICRON 30 mg/tab.

Batches

1

2

3

4

5

Concentration  mg/tab.

29.92

29.73

29.85

29.74

29.72

SD mg/tab.

0.06

0.62

0.48

0.44

0.26

RSD %

0.20

2.09

1.61

1.48

0.87

Per %

99.73

99.10

99.50

99.13

99.07

Range Per %

99.07 – 99.73

Product

UNICRON 60 mg/tab.

Batches

1

2

3

4

5

Concentration  mg/tab.

59.97

59.87

59.74

59.62

59.83

SD mg/ tab

0.87

1.01

0.94

0.63

0.97

RSD %

1.45

1.69

1.57

1.06

1.62

Per %

99.95

99.78

99.57

99.37

99.72

Range Per %

99.37 – 99.95

Product

UNICRON 80 mg/tab.

Batches

1

2

3

4

5

Concentration  mg/tab.

79.98

79.66

79.93

79.58

79.44

SD mg/tab.

1.52

0.30

0.45

1.05

1.21

RSD %

1.90

0.38

0.56

1.32

1.52

Per %

99.98

99.58

99.91

99.48

99.30

Range Per %

99.30 – 99.98

*Mean for five replicates.


 

CONCLUSION:

We developed a new spectrophotometric color ion-pair complexationmethod, which is suitable for the quantification of (GLZ) in raw material and tablets formulations after forming color ion-pair complex. This method can be successfully used in routine analyses. The proposed method is simple, sensitive, rapid, a little cost. It could applied for quality control of (GLZ) in pharmaceutical factories. The levels of (GLZ) in the analyzed preparations were found to be within the permissible limits set by the BP legislation1.

 

ACKNOWLEDGEMENT:

The Ministry of High Education in Syria financially and technically supported this work through department of Chemistry, Faculty of Science, University of Aleppo, Syria.

 

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Received on 31.07.2022            Modified on 24.09.2022

Accepted on 30.11.2022           © RJPT All right reserved

Research J. Pharm. and Tech 2023; 16(4):1714-1720.

DOI: 10.52711/0974-360X.2023.00282