You are hereSIMULTANEOUS DETERMINATION AND VALIDATION OF TELMISARTAN AND RAMIPRIL IN PHARMACEUTICAL DOSAGE FORM BY RP – HPLC AND HPTLC

SIMULTANEOUS DETERMINATION AND VALIDATION OF TELMISARTAN AND RAMIPRIL IN PHARMACEUTICAL DOSAGE FORM BY RP – HPLC AND HPTLC


Validation
Linearity and Range

The linearity of an analytical procedure is its ability (within a given range) to obtain the test results, which are directly proportional to the concentration of analyte in the sample. Linearity was assessed by performing single measurement at several analyte concentrations. A minimum of five concentration were recommended for linearity studies

To evaluate the linearity range of Telmisartan and Ramipril, varying concentration of standard stock solution is diluted with mobile phase to give minimum of five concentrations in the range of 120 to 280 µg/ml of Telmisartan and 15 to 35 µg/ml of Ramipril. A calibration curve was constructed for each sample for each samSple by plotting the peak areas obtained against the concentration.

Telmisartan
There exists a linear relationship in the concentration range of 120 to 280µg/ml  for Telmisartan. The data are tabulated  shows the line of best fit for Telmisartan.

Linearity of Telmisartan

LINEARITY DATA FOR TELMISARTAN

Concentration

(µg/ml)

Peak area

120

160

200

240

280

11518.6

15320.3

19205.7

23099.9

26282.9

From the data obtained Correlation coefficient, Y-intercept and Slope were calculated to provided mathematical estimates of the degree of linearity for Telmisartan and it is tabulated

ANALYTICAL PERFORMANCE PARAMETERS OF TELMISARTAN

Parameters

Telmisartan

Linear Dynamic Range

Correlation coefficient (r)

Slope (m)

Intercept (c)

120-280  µg/ml

0.9995

94.728

116.5

Ramipril

There exists a linear relationship in the concentration range of 15 to 35µg/ml for Ramipril. The data are tabulatedshows the line of best fit for Ramipril...

LINEARITY DATA FOR RAMIPRIL (RAMI)

Concentration      (µg/ml)

Peak area

15

20

25

30

35

4407.1

6012.3

7498.1

8994.4

1031.2

From the data obtained Correlation coefficient, Y-intercept and Slope were calculated to provide mathematical estimates of the degree of linearity for Ramipril and it is tabulated

Parameters

Ramipril

Linear Dynamic Range

Correlation coefficient (r)

Slope (m)

Intercept (c)

     15 - 35µg/ml

     0.9996

     297.16

     13.154

Analytical Performance Parameters Of Ramipril

Following fig shows the overlain densitogram for linearity of TELM and RAMI.

Overlain densitogram for Linearity of Telmisartan and Ramipril

SYSTEM SUITABILITY
System suitability parameters like resolution and asymmetry factor or tailing factor are studied and tabulated in following table.

SYSTEM SUITABILITY DATA

Parameters

TELM

RAMI

Resolution

                              2.85

Tailing factor

1.6

          1.2

SYSTEM PRECISION
Standard solution with the concentration same as that used for assay is spotted in replicate and the areas of peak in the developed chromatogram are noted down. The values of mean and percentage relative standard deviation are calculated and tabulated in following table

SYSTEM PRECISION

S.NO

Area of TELM

Area of HCTZ

1

2

3

4

5

19195.6

19189.7

19220.4

19230.5

19180.4

7480.4

7485.6

7392.8

7479.6

7486.4

Mean

19203.32

7464.96

%R.S.D

0.11

0.54

METHOD PRECISION
Sample solution at the working concentration is spotted in replicate and percentage label claim is calculated for both the drugs. The mean and percentage relative standard deviation are calculated for percentage label claim calculated for the drugs.

The percentage label claims for the drugs are calculated using the same formula, used for assay calculation.

The average/mean, percentage relative standard deviation for the percentage label claims are calculated for both the drugs and the data are tabulated in Table

METHOD PRECISION DATA

S.NO


%Label claim

TELM

HCTZ

1

2

3

4

5

99.01

98.99

99.15

98.20

98.94


99.06

99.12

97.90

99.04

99.14


Mean

99.05

98.85

%R.S.D

0.37

0.53

RECOVERY STUDIES
To ensure the reliability of the method, recovery were carried out by mixing a known quantity of standard drug with the pre-analyzed sample and the content were reanalyzed by the proposed method.

The study was conducted using 10% recovery. 10 tablets were crushed along with 40mg of Telmisartan and 5mg of Ramipril (for 10%). The method of analysis is same as that of assay. The percentage recovery is calculated using the formula:

                                         Amount of drug received

Percentage Recovery  =  _______________________ x 100

                                         Amount of drug added

The results are tabulated in tableand for densitogram

Recovery Densitogram of Telmisartan and Ramipril
1. Telmisartan
2. Ramipril

RECOVERY STUDIES

Sample

Amt. of std. added (mg)

Amt. of drug recovered (mg)

% Recovery

Mean% Recovery

TELM

      4

      4

      4

3.989

3.982

4.012

      99.72

      99.55

      100.3

99.85

   

RAMI

     0.5

     0.5

     0.5

      0.496

      0.501

      0.499

      99.2

     100.2

      99.8

99.73

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