4.

RESULT AND DISCUSSION:

4.1. Result of experimental work: Preformulation study: The Preformulation study of Anti-Parkinson agents was performed by various physico-chemical parameters including description, solubility, partition coefficient, loss on drying, melting point.
S.no Marketed formulation Colour Meltin g point Parameters FTIR Loss on drying Assay Solubilit y Partition coefficien t

Rn1

creamywhite 241 to 245C

(CH3 bending) (C=C) (C=O) C-H bend benzene

0.1

249nm, slope 0.0285

Soluble in methano l. in water

2.64

Pm1

faintly yellow

222 C

(CH3 bending) C-H NH stretchin g

0.05

205nm, slope 0.097

soluble in water and alcohol

4.35

Th1

creamywhite 336C

C=C C=C C=O (CH3 bending)

0.1

250nm, slope 1.007

Slightly 4.21 soluble in water. Soluble in methano l

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Calibration curve for Anti-Parkinson agents: Calibration curve of both drugs was carried out with UV-Vis Agilent

Spectrophotometer, technologies.

Cary-60

UV-Vis

Spectrophotometer,

Table 4.2: Calibration curve data of Ropinirole HCl.

Conc. (g/ml)
2 4 6 8 10 12 14 16 18 20

Absorbance
0.062
0.118 0.209

0.316 0 .421 0 .51 0.624 0.728 0.816 0.921

Abs
1 0.9 0.8 0.7 Absorbance 0.6 0.5 0.4 0.3 0.2 0.1 0 0 10 20 30 Conc. mcg/ml Abs Linear (Abs) y = 0.0443x R = 0.9852

Fig.4.1: calibration curve of Ropinirole HCl.

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Calibration Curve of Trihexyphenidyl HCl

Table 4.3: Calibration curve data of Trihexyphenidyl HCl. Conc. (g/ml)

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Absorbance
0
0.019 0.0285

0.0384 0 .0475 0 .0584 0.0673 0.0772 0.0844 0.0921 0.102

abs
0.12 0.1 0.08 0.06 0.04 0.02 0 0 0.5 1 1.5 abs Linear (abs) y = 0.097x + 0.0074 R = 0.9912

Figure 4.2: Standard curve of Trihexyphenidyl HCl in 0.01N HCl at 250nm

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Calibration Curve of Promethazine HCl :

Table 4.4: Calibration curve data of Promethazine HCl.

Conc. (g/ml)
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Absorbance
0
0.0591 0.1625

0.2508 0 .3688 0 .4655 0.5728 0.6857 0.7651 0.8707 0.9511

abs
1.2 1 0.8 abs 0.6 0.4 0.2 0 0 0.5 1 1.5 Linear (abs) Linear (abs) y = 1.007x - 0.0386 R = 0.9989

Figure 4.3: Standard curve of Promethazine HCl in water at 205nm

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4.1.2. Result obtained after evaluation of different marketed formulation (tablets): Table 4.5: Different variables for evaluation of anti- Parkinson agents. Formulation Hardness (Kg/cm2) %variation (upper limit, lower limit) Rn1 Th1 Th2 0.3 +7.4, -0.826 0.2 +6.060, -1.5 0.3 0.00 Th3 Pm1 0.3 +0.418, -0.418 1 0.0 Pm1 2 +2.32, -6.976 5.12 min 0.00% 1.12 min. 0.00% 54 sec. 0.00% 1.23 min. 0.00% 1.19 min. 0.00% 6.16 min. 0.00% Disintegration Time (min.) Friability (%)

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4.1.3. Determination of dissolution study: Table 4.6: Data for cumulative drug release of different anti- Parkinson formulation (tablet)

Time (min) 0 5 10 15 20 25 30 35 40 45

% CDR (Rn1) 0.0

9.48 15.84 20.61404 30.11404 36.48246 42.83333 55.5 72.9386 84.08772

% CDR (Pm1) 0.0

50.67527 55.54618 60.14896 70.02483 73.91261 79.81132 83.83317 88.30189 96.16683

% CDR (Pm2) 0.0

38.65442 50.5859 55.14399 60.59583 63.99206 70.02483 72.92949 77.48759 81.46475

% CDR (Th1) 0.0

40.75472 45.40218 50.5859 56.48461 60.59583 65.95829 70.51639 74.9851 80.97319

% CDR (Th2) 0.0

40.75472 49.06653 52.99901 56.70804 62.11519 67.47766 71.41013 76.01291 87.8997

% CDR (Th3) 0.0

42.72095 48.66435 52.14995 54.11619 61.08739 63.05362 71.27607 75.87885 80.66038

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120

100

80

%CDR(Rn1) %CDR(Pm1)

60

%CDR(Pm2) %CDR(Th1)

40

%CDR(Th2) %CDR(Th3)

20

0 0 10 20 30 40 50

Fig 4.4: % CDR curve of different marketed anti-Parkinson agents.

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DISCUSSION:
4.1.1. Standard Curve: In the preformulation study the standard curve of Ropinirole, Promethazine HCl and Trihexyphenidyl HCl was obtained to check the purity of the drug sample. The -max of the sample drug was compared with that of the reference standard which is 249.0 nm, 250.0 nm and 205.0 nm for Ropinirole, Promethazine HCL and Trihexyphenidyl HCl respectively the calibration curve is performed by UV-Vis Spectrophotometer (carry-60 UV-Visible, Agilent technologies) and found satisfactory.

4.1.2.

The FTIR: The Fourier Transform Infrared spectroscopy was performed by (cary-630 FTIR-Spectrophotometer, Agilent technologies). Spectra of the pure Ropinirole, Promethazine HCl and Trihexyphenidyl HCl was carried out and there FTIR spectra of are given in figure 2.1 2.2 and figure 2.3 respectively.

4.1.3. Solubility: Determination of solubility of the pure drug Ropinirole, Promethazine HCl and Trihexyphenidyl HCl in different solvent (i.e. methanol, ethanol and distilled water) was studied and it has been found that the drug shows its maximum solubility in methanol and freely soluble in distilled water.

4.1.4. Partition coefficient: Partition coefficient of the pure drug sample of Ropinirole, Promethazine HCl and Trihexyphenidyl HCl is carried out with the help of UVVis Spectrophotometer at 240.0 nm, 250.0 nm and 205.0 nm respectively and we found that at equilibrium drug having low partition co-efficient value in water and maximum value in organic phase.

4.1.5.

Evaluation of formulation (tablet):

4.1.5.1. Weight variation: According to the Indian Pharmacopoeia for those tablets which are less than 80mg the percentage deviation is 10% of average weight of 20 tablets. All tablets of chosen marketed formulation were come under the limit

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of weight variation. So result is that, all marketed formulations are passed in weight test.

4.1.5.2. Hardness: In all the formulations, hardness test showed good mechanical strength. hardness of the tablets was within the range of 0.0 to 4.0kgs.

4.1.5.3. Disintegration time: The formulations showed disintegration time between the ranges of 25seconds to 7.50 minutes.

4.1.5.4. Friability: The friability of the all formulations was found to be 0%, indicated that tablets had a good mechanical resistance, so the tablets are passed in friability test.

4.1.5.5. Dissolution: Dissolution study was carried out in USP II type dissolution apparatus (paddle type) with (DS-8000, LABINDIA). Dissolution study was performed at 100 rpm in 900ml (distilled water for Ropinirole HCl formulations, 0.01N HCl for Promethazine HCl formulations and Trihexyphenidyl HCl) .The temperature was maintained at 37 0.2oC throughout the dissolution process. The absorbance of withdrawn sample was measured by UV-Vis spectrophotometric method at 249.0 nm (Ropinirole HCl) and 250.0 nm for (Trihexyphenidyl HCl) and 205.0 nm (Promethazine HCl). In-vitro dissolution studies showed that all marketed formulation released drug more than 90% within 45 minutes, but the percentage release of formulation FL is greater than any other marketed formulation. The results are shown in figure 4.4.

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