You are hereSPECTROPHOTOMETRIC ESTIMATION OF TOLPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM IN SYNTHETIC MIXTURE BY DUAL WAVELENGTH METHOD

SPECTROPHOTOMETRIC ESTIMATION OF TOLPERISONE HYDROCHLORIDE AND DICLOFENAC SODIUM IN SYNTHETIC MIXTURE BY DUAL WAVELENGTH METHOD


RESULTS AND DISCUSSION
In dual wavelength method, the primary requirement for developing a method for analysis is that the entire spectra should follow the beer’s law at all the wavelength, which was fulfilled in case of both these drugs. In this Dual Wavelength Spectrophotometry method the linearity was observed in the concentration range of 2-18 µg/ml with co-efficient of correlation, (r2) = 0.999 for TOL by absorbance difference at 257 nm and 306.20 nm. For DIC the linearity was observed  in the concentration range of 2-18 µg/ml with co-efficient of correlation, (r2) = 0.997 by absorbance difference at 243.40  nm and 265.40 nm.

The RSD values of TOL were found to be 0.22 %. The RSD value of DIC was found to be 0.92 % . Relative standard deviation was less than 2 %, which indicates that proposed method is repeatable. The low RSD values of interday (0.22-0.42 %  for TOL and 0.26-0.86 % for DIC) and intraday (0.15 – 0.67 % for TOL and 0.16 – 0.85 % forDIC) variation for TOL and DIC, reveal that the proposed method is precise. LOD and LOQ values for TOL were found to be 0.66 and 2.00 µg/ml, respectively. LOD and LOQ values for DIC were found to be 0.27 and 0.83 µg/ml respectively. These data show that method is sensitive for the determination of TOL and DIC. The regression analysis data and summary of validation parameters for the proposed method is summarized in Table 1.

The recovery experiment was performed by the standard addition method. The mean recoveries were 99.68 ± 0.31 and 99.67 ± 0.39 %for TOL and DIC, respectively (Table 2). The resultsof recovery studies in DIC state that the proposed method is highly accurate. The proposed validated method was successfully applied to determine TOL and DIC in their combined dosage form. The results obtained for TOL and DIC were comparable with the corresponding labeled amounts (Table 3). No interference of the excipients with the absorbance of interest appeared; hence the proposed method is applicable for the routine simultaneous estimation of TOL and DIC in pharmaceutical dosage forms.

Table 1: Regression analysis data and summary of validation parameters for the proposed method

PARAMETERS

TOL at  250.60nm

DIC at 311.20nm

Concentration range (µg/ml)

2-18

2-18

Slope

0.061

0.001

Intercept

0.013

0.007

Correlation coefficient

0.999

0.997

LOD (µg/ml)

0.66 

0.27

LOQ (µg/ml)

2.00

0.83

Repeatability (RSD, n = 6), %

0.2199

0.9245

Precision (RSD), %


Interday (n = 6),%

Intraday (n = 6), %

0.22-0.42

0.15 – 0.67

0.26-0.86

0.16 – 0.85

Recovery

99.68 ± 0.31

99.67 ± 0.39

aRSD = Relative standard deviation. bLOD = Limit of detection. cLOQ = Limit of quantification. dS. D. is standard deviation

Table 2: Recovery data of proposed method

Drug

Level

Amount of sample taken (µg/ml)

Amount of standard   spiked (%)

Mean

% Recovery ± SD*

TOL

I

10

50 %


99.50 ± 0.45

II

10

100 %


100.23  ± 0.10

III

10

150 %

99.31  ± 0.36

DIC

I

10

50 %


100.21 ± 0.65

II

10

100 %


99.40 ± 0.37

III

10

150 %

99.42 ± 0.15

 
S. D. is Standard deviation and n is number of replicate

Table 3: Analysis of TOL and DIC in synthetic mixture

Sample No.

Amount Taken

Amount Found

% Assay

TOL

(mg)

DIC

(mg)

TOL

(mg)

DIC

(mg)

TOL

%

DIC

%

1

150

50

150.81

50.35

100.54

100.71

2

150

50

150.81

50.00

100.54

100.00

3

150

50

151.21

49.28

100.81

98.57

4

300

100

299.73

99.28

99.91

100.71

5

300

100

296.61

100.35

98.87

100.35

6

300

100

300.30

101.07

100.12

99.64

Mean

100.13

99.99

S.D.

0.6991

0.8130

 
S. D. is standard deviation and n is number of replicate

CONCLUSION
The proposed Spectrophotometric method was found to be simple, sensitive, accurate and precise for determination of TOL and DIC in synthetic mixture. The method utilizes easily available and cheap solvent for analysis of TOL and DIC hence the method was also economic for estimation of TOL and DIC from synthetic mixture. The common excipients and additives are usually present in the synthetic mixture do not interfere in the analysis of TOL and DIC in method, hence it can be conveniently adopted for routine quality control analysis of the drugs in mixture or combined pharmaceutical formulation.

ACKNOWLEDGEMENT
The authors are thankful to Torrent Research Centre, Gandhinagar, India and Acme Pharmaceutical Ltd., Ahmadabad, India for providing gift sample of TOL and DIC, respectively for carry out the research work. The authors are highly thankful to Center for Health and Science Studies, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India for providing all the facilities to carry out the research work.

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