UV (Ultraviolet) testing is a commonly used technique in the pharmaceutical industry to determine the purity and concentration of a drug substance or a drug product. SOP for Testing Itopride 50mg Tablet by UV spectroscopy is based on the measurement of the absorption of UV light by a compound in a solution.
PURPOSE:
To describe the procedure for analysis at in-process and finished stage of Itopride 50 mg Tablet.
SCOPE:
This SAP gives a detailed outline for the finished product analysis of Itopride 50 mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis.
RESPONSIBILITY:
QC Analyst is responsible for physical / chemical testing and preparing standard analytical procedure.
It is the responsibility of QC Manager to assist and ensure Testing Procedure as per SAP and to make certain that this SAP is followed in its entirety, reviewed regularly and revised as necessary.
REFERENCE:
INNOVATORS SPECIFICATIONS
MATERIAL AND EQIUPMENT:
- UV Spectrophotometer
- Dissolution apparatus
- Friability apparatus
- Hardness apparatus
- Disintegration Tester
- Vernier Caliper
- Analytical Balance
- Moisture analyzer
- Mortar and pestle
- Spatula
- Filter Paper
- Magnetic Stirrer & Hot Plate
- Sonicator
- Vacuum Pump
- Glassware
- 0.1N HCl
- Distilled water
PROCEDURE:
SOP for Testing Itopride 50mg Tablet by UV spectroscopy
FINAL MIX Description: White powder.
Procedure: Take 2.0 g of the test sample in a watch glass and observe visually with black background. Check the appearance of color, nature and any visible foreign particles.
Identification: (By UV SPECTROPHOTOMETER)
The spectrum of the sample preparation corresponds to spectrum of the standard preparation as obtained in the assay.
Assay: (Limit: 90%-110%)Compression Weight of Powder/Tablet: ….. mg /tablet
Procedure:
UV testing can be a useful analytical technique for the quality control of pharmaceuticals, including Itopride tablets. However, it is important to note that this is only one of many analytical methods used in the industry, and it should be used in conjunction with other tests to ensure the quality and safety of the product.
Standard Solution:
Take 50 mg of Itopride HCl WS dissolved in water and make up the volume to 100mL with water. Shake, and sonicate for 5 minutes to facilitate dissolution
Take 2 mL from standard stock solution and make up the volume to 50 mL with water.
Sample solution:
Take 5gram of sample grind them to fine powder. Take compression weight of finally grinded powder and dissolved in water and make up the volume to 200 with water. Shake by mechanical mean for 10 minutes to disperse and allow any insoluble matter to settle.
Pass a portion of the sample stock solution through a suitable filter of 0.45um pore size.
Transfer the 2 mL of filtrate to a 25mL volumetric flask make up volume with water. Take reading at UV spectrophotometer at 258 nm using water as blank.
To test Itopride tablets using UV, the following steps can be taken:
Preparation of sample: Take a few Itopride tablets and crush them to a fine powder. Weigh accurately about 20 mg of the powder and dissolve it in 100 ml of methanol. Mix it well and filter the solution through a 0.45 µm filter.
Calibration: Prepare a series of standard solutions of Itopride in methanol of known concentrations ranging from 1 µg/mL to 10 µg/mL. Use these solutions to prepare a calibration curve by plotting the absorbance values obtained at a specific wavelength against the concentration of Itopride.
Instrumentation: Use a UV spectrophotometer to measure the absorbance of the sample solution and the standard solutions at a specific wavelength of 275 nm. Set the instrument to zero using methanol as a blank.
Analysis: Measure the absorbance of the sample solution at 275 nm and determine the concentration of Itopride using the calibration curve. The concentration of Itopride in the sample can then be calculated based on the weight of the sample used.
Calculation of results: Calculate the percentage of Itopride present in the tablet by dividing the concentration of Itopride in the sample by the weight of the tablet and multiplying by 100.
Uniformity of Dosage Units: (By Weight Variation)
Weigh 20 tablets individually and calculate the average weight as:
Average weight = (WeightOf 20 Tablets)/20
Weigh all these tablets individually and mark among these weights maximum (WMax) & minimum (WMin) weight tablets. Calculate the maximum and minimum variation in percent as:
Maximum% age variation =((WMax) – (WAvg.))/WAvg×100
Minimum % age variation ((WMin) – (WAvg.))/WAvg×100
Hardness Test & Dimensions:
Perform the hardness test on 10 tablets and take the average. Power on the instrument and regulate zero adjustment and preset the ‘’HARDNESS’’ and “Thickness” mode. Place the tablet on the test plate, begin testing and read the hardness thickness and diameter. Clean the shattered tablet and print out test results, perform the test on 10 tablets and take the average.
Hardness Standard Limit:
Friability Test:
For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of 10 whole tablets. The tablets should be carefully dedusted prior to testing. Accurately weigh the tablet sample, and place the tablets in the drum. Rotate the drum 100 times, and remove the tablets. Remove any loose dust from the tablets as before, and accurately weigh. Generally, the test is run once. If obviously cracked, cleaved, or broken tablets are present in the tablet sample after tumbling, the sample fails the test. If the results are doubtful or if the weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined. A maximum mean weight loss from the three samples of not more than 1.0% is considered acceptable for most products.
% FRIABILITY= W1-W2/W1 x 100
Disintegration Test:
Place the beaker filled with water into the beaker stand inside the bath and. Switch on the instrument, set the temperature at 37ºC± 2º C and wait till the temperature of the beaker reaches to the 37ºC± 2º C. Engage the basket on basket hook put the tablets in 6 tubes individually and place the discs then start the oscillations and timer. Note the disintegration time of all the six tablets.
Note the Disintegration time of 1st tablet to the last tablet.
Disintegration Time: NMT 15 minutes at 370C ± 20C
Acceptance criteria of disintegration for tablets:
If 1 or 2 tablet fail to disintegrate completely repeat the test on 12 additional tablets, not less than 16 of the total of 18 tablets tested disintegrate completely.
Dissolution Test:
Preparation of 0.1N Hydrochloric Acid:
Take 8.5 mL of 37% hydrochloric acid in 1000 mL flask, make up volume with water. Shake well.
USP Apparatus: USP Apparatus II Peddle
Medium: 900mL 0.1NHCl
Speed: 50 rpm
Time: 30 Minute
Medium Temperature: 37º ± 0.5º
Recommended Sampling Time: Itopride HCl: 30 Minute
Diluent: Dissolution medium
Standard solution:
Take 69.4 mg Itopride HCl WS in 100mL volumetric flask add 10 mL 0.1N HCl to dissolve Itopride HCl then make up volume with medium.
Take 2 mL from standard stock solution and make up the volume upto100 mL with medium.
Sample solution: Passa portion of solution under through a suitable filterof 0.45-um pore size.
Take 5 mL from sample filtrate and make up the volume upto20 mL with medium.
Instrumental Conditions
Mode:UV
Analytical wavelength: UV 258 nm
Blank: Medium
Calculations:
Sample Absorbance x Standard Concentrationx Potency
Standard Absorbance x Sample Concentration
Tolerance:
The amount of drug dissolve in solution for each tablet is not less Than 80% Q of the amount stated on the label for Itopride HCl at 30 minute.