Testing Mirtazapine tablets should be done by a qualified healthcare professional or a laboratory. They will use specific methods and equipment to ensure the quality, purity, and consistency of the medication. SOP for Finished Product Analysis of Mirtazapine Tablet By UV and HPLC Method However, if you are referring to verifying the authenticity of the tablets.
The United States Pharmacopeia (USP) provides standards and guidelines for testing the quality of pharmaceutical products, including Mirtazapine tablets. Here is a general overview of the testing procedures that may be followed according to the USP:
To describe the procedure for analysis at the in-process and finished stage of Mirtazapine Tablet.
This SAP gives a detailed outline for the finished product analysis of Mirtazapine mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis.
QC Analyst is responsible for physical/chemical testing and preparing standard analytical procedures.
It is the responsibility of the QC Manager to assist and ensure the Testing Procedure as per SAP and to make certain that this SAP is followed in its entirety, reviewed regularly, and revised as necessary.
USP 44, NF39
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
- Methanol AR Grade
- Distilled water
- Tetramethylammonium hydroxide pentahydrate
- Hydrochloric Acid
SOP for Finished Product Analysis of Mirtazapine Tablet By UV and HPLC Method
A white to off white granular 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.
The spectrum of the sample preparation corresponds to spectrum of the standard preparation as obtained in the assay.
The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay.
Loss on Drying: (By Moisture Analyzer)
Turn on instrument 20 minute before the test. Take 2 g powder spread uniformly on Moisture Analyzer plate. Close the lid and press start button.
NMT 3.0% when determined by LOD Apparatus, Use 2.0 g of powder.
Assay: (Limit: 90%-110%)
Diluent: Acetonitrile and water (1:1)
Buffer: Dissolve18.0 g of tetramethylammonium hydroxide pentahydrate in 950 mL of water. Adjust with phosphoric acid to a pH of 7.4, and dilute with water to 1 L.
Mobile phase: Acetonitrile, methanol, tetrahydrofuran, and Buffer(15: 12.5: 7.5: 65)
Standard solution: 0.3 mg/mL of USP Mirtazapine RS in Diluent
Nominally 0.3 mg/mL of mirtazapine(from an amount equivalent to the weight of 1 Tablet from NLT 20 finely powdered Tablets) in Diluent. Shake vigorously for 10 min, centrifuge an aliquot, and use the clear supernatant.
(See Chromatography (621), System Suitability.)
Detector: UV 290 nm
Column: 4.6-mm x 25-cm; packing L1
Column temperature: 40°
Flow rate: 1.5 mL/min
Injection volume: 10 uL
Sample: Standard solution
Column efficiency: NLT 7000 theoretical plates
Tailing factor: NMT2.0
Relative standard deviation: NMT1.5%
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of Mirtazapine (C17H19N3) in the portion of Tablets taken:
Result = (Ru/Rs) x (Cs/Cu) x 100
Ru=peak response from the Sample solution
Rs= peak response from the Standard solution
Cs = concentration of USP Mirtazapine RS in the Standard solution (mg/mL)
Cu =nominal concentration of the Sample solution(mg/mL)
Average Sample AUC x Standard Concentration x Ave. Weight of Tablet x Potency
Average Standard AUC x Sample Concentration x Label Claim x Factor
Limit: Mirtazapine: 90%-110%of the labeled amount
ALTERNATE METHOD By UV
Take 30 mg of Mirtazapine WS dissolved in 0.1N HCl and make up the volume to 100mL with 0.1N HCl. 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 0.1N HCl.
Take compression weight of finally grinded granules equivalent to 30 mg Mirtazapine and dissolved in 0.1N HCl and make up the volume to 100mL with 0.1N HCl. 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 50mL volumetric flask make up volume with 0.1N HCl. Take reading at UV spectrophotometer at 315 nm using 0.1N HCl as blank.
Sample Absorbance x Standard Concentration x Ave. Weight of Tablet x Potency
Standard Absorbance x Sample Concentration x Label Claim x Factor
Limit: Mirtazapine: 90%-110%of the labeled amount
Hardness Test :
Perform the hardness test on 10 tablets and take the average. Power on the instrument and regulate zero adjustment and preset the ‘’HARDNESS’’. Clean the shattered tablet and print out test results, perform the test on 10 tablets and take the average.
Hardness Standard Limit: Not more than 10.00 Kg
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 x 100/W1
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.
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.
Medium: 0.1 N hydrochloric acid; 900 mL
Apparatus 2: 50 rpm
Time: 15 min
Sample solution: Pass a portion of the solution under test through a suitable filter. Dilute with Medium, if necessary.
Standard solution: USP Mirtazapine RS in Medium in concentration similar to the one expected in the Sample solution
(See Ultraviolet-Visible Spectroscopy (857).)
Analytical wavelength: 315 nm
Samples: Sample solution and Standard solution
Calculate the percentage of the labeled amount of mirtazapine(C17H19N3) dissolved:
Result =(Au/As) x C, x V x (1/L) x 100
Au =absorbance of the Sample solution
As = absorbance of the Standard solution
Cs =concentration of USP Mirtazapine RS in the Standard solution(mg/mL)
V =volume of the Medium, 900 mL
L =Label claim (mg/Tablet)
Tolerances: NLT 80% (Q) of the labeled amount of mirtazapine(C17H19N3) is dissolved.
CONTENT UNIFORMITY TEST: (ByHPLC)
Proceed as directed in the assay.
Calculation of Acceptance Value (AV):
L1= ≤ 15 (For 10 Unit)
L2= ≤ 25 (For 30 Unit)
General Formula = M-x̄ ±ks