Solifenacin Succinate 5 mg Tablet is a medication used to treat overactive bladder symptoms, such as urgency, frequency, and incontinence. The testing procedure for this medication involves a combination of preclinical and clinical studies to evaluate its safety, efficacy, and pharmacokinetics.
Preclinical studies involve testing the medication in animal models to determine its toxicity, pharmacokinetics, and pharmacodynamics. These SOP for Solifenacin Succinate 5 mg Tablet Testing by UV HPLC Method studies help researchers identify any potential safety concerns and determine appropriate dosages for humans.
Clinical studies involve testing the medication in human subjects to evaluate its safety and efficacy. These studies are typically conducted in several phases, starting with small studies in healthy volunteers to determine the medication’s pharmacokinetics and dosing. If the medication is found to be safe and effective, larger studies are conducted in patients with overactive bladder to evaluate its clinical effectiveness.
During clinical studies, researchers also monitor adverse events and side effects, as well as drug interactions with other medications. They may also conduct additional tests to evaluate the medication’s effects on various parameters, such as bladder capacity, frequency, urgency, and incontinence.
Once a medication is approved, post-marketing surveillance may also be conducted to monitor for any potential long-term safety concerns or adverse events.
Overall, testing for Solifenacin Succinate 5 mg Tablet is a rigorous process that involves multiple stages of evaluation to ensure its safety and effectiveness for treating overactive bladder symptoms.
To describes the procedure for analysis at in-process and finished stage of Solifenacin Succinate 5 mg Tablet.
This SAP gives detailed outline for the finished product analysis of Solifenacin Succinate 5 tablet and will cover In process testing activities on physical, chemical & instrumental basis.
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.
MATERIAL AND EQIUPMENT:
- UV Spectrophotometer
- Dissolution apparatus
- Friability apparatus
- Hardness apparatus
- Disintegration Tester
- Vernier Caliper
- Analytical Balance
- Moisture analyzer
- Mortar and pestle
- Filter Paper
- Magnetic Stirrer & Hot Plate
- Vacuum Pump
SOP for Solifenacin Succinate 5 mg Tablet Testing by UV HPLC Method
A 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: 200 mg /tablet
Take 50 mg of Solifenacin Succinate 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 100 mL with water
Take weight of grinded powder equivalent to 10mg of Solifenacin Succinate and dissolved in water and make up the volume to 250mL with water. Sonicate for 5 minutes, 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 5 mL of filtrate to a 20mL volumetric flask make up volume with water. Take reading at UV spectrophotometer at 210 nm using water as blank.
Sample Absorbance x Standard Concentration x Ave. Weight of Tablet x Potency
Standard Absorbance x Sample Concentration x Label Claim
Limit: Solifenacin Succinate: 90%-110%of the labeled amount
Uniformity of Dosage Units: (By Weight Variation)
Weigh 20 tablets individually and calculate the average weight as:
Average weight = (Weight Of 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
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.
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
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 tablets fail to disintegrate completely repeat the test on 12 additional tablets, not less than 16 of the totals of 18 tablets tested disintegrate completely.
USP Apparatus: USP Apparatus II Peddle
Medium: 500mL water
Speed: 50 rpm
Time: 15 Minute
Medium Temperature: 37º ± 0.5º
Recommended Sampling Time: Solifenacin Succinate: 15Minutes
Diluent: Dissolution medium
Standard solution: Take 50 mg Solifenacin Succinate WS in 100mL volumetric flask then make up volume with water.
Take 2 mL from standard stock solution and make up the volume upto100 mL with medium.
Sample solution: Pass a portion of solution under through a suitable filter of 0.45-um pore size.
Analytical wavelength: UV 225 nm and background correction 320nm
Sample Absorbance x Standard Concentration x Potency
Standard Absorbance x Sample Concentration
The amount of drug dissolve in solution for each tablet is not less Than 80% of the amount stated on the label for Solifenacin Succinate at 15 minutes.
Take 06 blisters of tablet 03 filled and 03 empty. Dip these blisters in the bowl of leak test apparatus containing colored water. Create vacuum 250 mmHg and hold for one minute. Release vacuum and check the penetration of water inside the blisters. All blisters should be free of water.