FORMULATION AND EVALUATION OF AMOXICILLIN TRIHYDRATE MODIFIED RELEASE DOSAGE FORMS

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EQUIPMENTS USED:

Table 4.2: List of equipment used

Sr. No.

Equipments

Make

1

Digital Weighing Balance

Anameda series. Model no. model no:AA-2200

2

Mechanical Stirrer

Mayura analytical pvt. Ltd.

3

HPLC

Agilent technologies.

Model no.: 1120 compact LC

4

Tablet Compression Machine

Cadmach machinery co. pvt. Ltd., Type no.: CMD3-16

5

Tablet Hardness Tester

Ketan, Bombay. (Monsanto)

6

Friabilator (USP)

Campbell electronics

7

Dissolution Apparatus

S.P.Automatics, Bombay.

Model no:SP/DT/8

8

Bulk density apparatus

Campbell electronics

9

Digital melting point apparatus

Veego scientific device,

Model no: MP-II

10

pH meter

Analab instrument

11

UV spectrometer

Carl zeissjena,

Model no.: VS U2-P.

SYSTRONIC 119.

12

Ultra sonicator

Toshniwal process instrument pvt. Ltd.

Model no.: SW4.5

13

Hand operated capsule filling machine

Pam pharmaceutical and allied machinery company Pvt. Ltd.

Model no.:SS072

 

ANALYTICAL METHODS

Preparation of Buffers and Reagents:
50mM of potassium phosphate monobasic buffer pH 4:
Dissolve 6.8gm of potassium di-hydrogen ortho-phosphate in 1000ml water. Adjust pH 4 by using 1M of phosphoric acid.

50mM of potassium phosphate monobasic buffer pH 6: Dissolve 6.8gm of potassium di-hydrogen ortho-phosphate in 1000ml water. Adjust pH 6 by using 1M sodium hydroxide.

50mM of potassium phosphate monobasic buffer pH 6.8: Dissolve 6.8gm of potassium di-hydrogen ortho-phosphate in 1000ml water. Adjust pH 6.8 by using 1M sodium hydroxide.

1M sodium hydroxide: It prepared by dissolving 40gm of sodium hydroxide in sufficient water to produce 1000ml.

1M orthophosphoric acid: It prepared by diluting 98gm of phosphoric acid to 1000ml with water.

1)   Preparation of amoxicillin trihydrate standard stock solution (1000µg/ml) in distilled water: A standard stock solution of amoxicillin trihydrate was prepared by dissolving accurately weighed 100 mg of amoxicillin trihydrate in distilled water in a 100 ml volumetric flask and the volume was made up to 100 ml by using distilled water to obtain a stock solution of 1000 mg/ml.

Determination of analytical wavelength: From the standard stock solution, 1 ml was pippetted into 10 ml volumetric flask.  The volume was made up to 10 ml with distilled water. The resulting solution containing 100 mg/ml was scanned between 200 and 400 nm. The lmax was found to be 272.6nm

Calibration curve of amoxicillin trihydrate in distilled water: Accurately weighed quantity of amoxicillin trihydrate (100 mg) was dissolved in little quantity of distilled water and volume was made up to 100 ml with the same solution.  Appropriate aliquots were taken into different volumetric flasks and volume was made up to 10 ml with distilled water so as to get drug concentrations of 50, 100, 150, 200, 250, 300 and 350 mg/ml. The absorbencies of these drug solutions were estimated at lmax272.6 nm. This procedure was performed in triplicate to validate the calibration curve. The data are given in the Table 4.3.  A calibration curve constructed is shown in the Figure 4.1.

Table 4.3: Data for calibration curve of amoxicillin trihydrate in distilled water at 272.6 nm

No.

Concentration (ppm)

Absorbance at 272.6nm

(n=3)

1

50

0.133 + 0.005

2

100

0.264 + 0.003

3

150

0.395 + 0.006

4

200

0.522 + 0.000

5

250

0.652 + 0.010

6

300

0.785 + 0.007

7

350

0.914 + 0.002

Figure 4.1: Calibration curve of amoxicillin trihydrate in distilled water.

2)   Preparation of amoxicillin trihydrate standard stock solution (1000 µg/ml) in 50mM potassium phosphate monobasic buffer at 4 pH solution: A standard stock solution was prepared by dissolving accurately weighed 116 mg of amoxicillin trihydrate is equivalent to 100 mg of amoxicillin in little quantity of phosphate buffer (pH 4) solution in 100 ml volumetric flask. The volume was made up to 100 ml with phosphate buffer (pH 4) solution to obtain a stock solution of 1000 mg/ml.

Determination of analytical wavelength in phosphate buffer (pH 4) solution: From the standard stock solution, 1 ml was pippetted into 100 ml volumetric flask.  The volume was made up to 100 ml with phosphate buffer solution, pH 4. The resulting solution containing 10 mg/ml was scanned between 200 and 400 nm.  The lmaxwas found to be 272.2.

Calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 4: From the stock solution, appropriate aliquots were taken from the above solution into different volumetric flasks and made up to 10 ml with phosphate buffer solution pH 4, so as to get drug concentrations ranging from 50 to 350 mg/ml.  The absorbencies of these drug solutions were estimated at lmax272.2 nm.  This procedure was performed in triplicate to validate the calibration curve. The data are given in the Table 4.4.  A calibration curve constructed is shown in the Figure 4.2.

Table 4.4: Data for calibration curve of amoxicillin trihydrate in phosphate buffer, pH 4 at 272.2 nm

No.

Concentration (ppm)

Absorbance at 272.2nm

(n=3)

1

50

0.161 + 0.010

2

100

0.319 + 0.002

3

150

0.470 + 0.007

4

200

0.622 + 0.003

5

250

0.776 + 0.001

6

300

0.929 + 0.006

7

350

1.080 + 0.002

Figure 4.2: Calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 4.

3)   Preparation of amoxicillin trihydrate standard stock solution (1000 µg/ml) in 50mM potassium phosphate monobasic buffer at 6 pH solutions: A standard stock solution was prepared by dissolving accurately weighed 116 mg of amoxicillin trihydrate equivalent to 100 mg of amoxicillin in little quantity of phosphate buffer (pH 6) solution in 100 ml volumetric flask. The volume was made up to 100 ml with phosphate buffer (pH 6) solution to obtain a stock solution of 1000 mg/ml.

Determination of analytical wavelength in phosphate buffer (pH 6) solution: From the standard stock solution, 1 ml was pippetted into 100 ml volumetric flask.  The volume was made up to 100 ml with phosphate buffer solution, pH 6. The resulting solution containing 10 mg/ml was scanned between 200 and 400 nm.  The lmaxwas found to be 272.8.

Calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 6: From the stock solution, appropriate aliquots were taken from the above solution into different volumetric flasks and made up to 10 ml with phosphate buffer solution pH 6, so as to get drug concentrations ranging from 50 to 350 mg/ml.  The absorbencies of these drug solutions were estimated at lmax272.8 nm.  This procedure was performed in triplicate to validate the calibration curve. The data are given in the Table 4.5.  A calibration curve constructed is shown in the Figure 4.3.

Table 4.5: Data for calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 6 at 272.8 nm

No.

Concentration (ppm)

Absorbance at 272.2nm

(n=3)

1

50

0.164 + 0.006

2

100

0.306 + 0.001

3

150

0.470 + 0.003

4

200

0.625 + 0.008

5

250

0.773 + 0.010

6

300

0.924 + 0.007

7

350

1.078 + 0.004

Figure 4.3: Calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 6.

4)   Preparation of amoxicillin trihydrate standard stock solution (1000 µg/ml) in 50mM potassium phosphate monobasic buffer at 6.8 pH solution: A standard stock solution was prepared by dissolving accurately weighed 116 mg of amoxicillin trihydrate equivalent to 100 mg of amoxicillin in little quantity of phosphate buffer (pH 6.8) solution in 100 ml volumetric flask. The volume was made up to 100 ml with phosphate buffer (pH 6.8) solution to obtain a stock solution of 1000 mg/ml.

Determination of analytical wavelength in phosphate buffer (pH 6.8) solution: From the standard stock solution, 1 ml was pippetted into 100 ml volumetric flask.  The volume was made up to 100 ml with phosphate buffer solution, pH 6.8. The resulting solution containing 10 mg/ml was scanned between 200 and 400 nm.  The lmaxwas found to be 272.6.

Calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 6.8: From the stock solution, appropriate aliquots were taken from the above solution into different volumetric flasks and made up to 10 ml with phosphate buffer solution pH 6.8, so as to get drug concentrations ranging from 50 to 350 mg/ml.  The absorbencies of these drug solutions were estimated at lmax272.6 nm.  This procedure was performed in triplicate to validate the calibration curve. The data are given in the Table 4.6.  A calibration curve constructed is shown in the Figure 4.4.

Table 4.6: Data for calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 6.8 at 272.6 nm

No.

Concentration (ppm)

Absorbance at 272.6nm

(n=3)

1

50

0.167 + 0.005

2

100

0.327 + 0.000

3

150

0.493 + 0.003

4

200

0.661 + 0.007

5

250

0.807 + 0.001

6

300

0.977 + 0.000

7

350

1.133 + 0.002

Figure 4.4: Calibration curve of amoxicillin trihydrate in phosphate buffer solution, pH 6.8.

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