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±5ºC 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 (4.5– 34.5)×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)½]
(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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