Evaluation of five Different Marketed Brands of Paracetamol Tablets using Quality Control Tests

 

Ganesh B. Vambhurkar*, Asha M. Jagtap, Akshata S. Gavade, Manish D. Rajput, Hrutuja V. Kambale, Manohar D. Kengar.

Rajarambapu College of Pharmacy, Kasegaon, Dist–Sangli, Maharashtra, INDIA–415404.

*Corresponding Author E-mail: ganeshvambhurkar100@gmail.com

 

ABSTRACT:

In most cases, supplement supplements give Paracetamol pills since OTC products are used in patients because most of them are antiviral and analgesic agents. The final objectives of this research were to compare and compare the various paracetamol tablets to show their sales in the Sangli district. Different brands of Ascetaminophen tablets (paracetamol tablets) have been collected from five categories in different pharmacies in the Sangli district. Several official books such as USP and BP were used to test the quality of the screen using different methods and several analytical tests to make this experiment work. In the evaluation of several brands of paracetamol, we were able to determine different parameters such as weight, duality, hardness, drug content, identity test, and dissolution time and dissolution profiles. We are pleased to try variations in weight and geometry that reflect acceptable brands with different brands. UV analysis of several samples revealed that NLT 95 percent active drug content is not available in the brand. Each brand tablet for benchmarking will give different results to each other, but the official books do not exceed the limit reached.

 

KEYWORDS: Quality control test, Different brands of paracetamol, Paracetamol, Comparative evaluation.

 

 


INTRODUCTION:

There is competition in pharmaceutical companies to discover new atoms for different ailments. Different pharmaceutical companies manufacture different generic drugs in different brands Small-scale pharmacological products are in India and can be distributed or marketed locally. Most studies have shown that most active pharmaceutical ingredients are used without seeing rural areas. Paracetamol is an analgesic and antipyretic widely used without a prescription. The chemical composition of acetaminophen (paracetamol) is shown (Figure 1).

 

 

Figure 1: Structure of Paracetamol

 

Normally there is an increase in body temperature, pain and fragile physical pain, and paracetamol used for the treatment of cold and flu[1]. Pharmacological substances results to administer the drug in the human body due to the concentration of the components of the pharmaceutical actives substance recipe during main objective factors that the amount of the label is dependent on such and its systemic availability of the tablet sutrikaranatila. Weight variation, rigidity, fracture, dissolution time, dissolution profile can have a significant effect on drug production. The physicochemical properties of active drug substances and excrement also affect the performance of the drug. All the above criteria are related to each other and the gastrointestinal route has an effect on the absorption and bioavailability of the medicinal substances. The final objective of the study was to evaluate the IPQ tests on different branded tablets due to standard quality standards [2].
 

MATERIAL AND METHODOLOGY:

Chemicals used:

The analytical sequences of several chemical products used for research are hydrochloric acid and sodium hydroxide, water commonly used for new research.

 

Apparatus and Equipments:

Sample Collection:

Comparative evaluation of the different brands of different companies of paracetamol of five brands, like Malidens-500, Paracip-500, Tyfy-500, Metacip-500 and Pyrigesic-500 from the shop to buy district doctor, and A, B, C, D and E. One brand is 500 mg per tablet, respectively, all perasitamol bought. All brands are being produced (Table 1) from the expiration date of two years from the date of the study, which is the shelf life of three years and practical pills are taken.

 

Study Design:

Acetaminophen tablets Different brands are studied by studying different parameters, such as weight diversity, rigidity, duplication, dissolution time, dissolution profile and drug content in the interruption.

 

METHODOLOGY:

Important for the development and evaluation of various analytical methods and tests. Evaluated according to USP and BP standards.
 

Identification Test of Paracetamol:

Different identification tests were performed as mentioned in British Pharmacopoeia.
 

Weight Variation:

The personal tablet of each brand was taken using the analytical balance. The percentage deviation is determined individually according to the USP.
 

Hardness Test:

Tension has been tested using the Monsanto hardness tester to keep the tablets upright. Then the load was applied and 10 tablets were used for this test according to the load cut of the tablet.

 

 

Friability:

Friability tests were performed with the Roche Friabrator; About 10 tablets are needed for this test. This test machine has been carried out maintaining the rotation speed at 25 rpm and maintaining the rotation period at least 4 minutes. The tablet is the weight after this process is completed and compared to the initial weight of the tablet. % Formula=[1-(w/wk)] using x 100 (where, % F=auspicious,%=initial weight of the tablet, w=weight of the tablet after the revolution=) This formula becomes the mathematical of the demons.
 

Tablet Disintegration:

The interruption test was performed using the test device; 6 tablets are stored in the device in the interruption test. The temperature of the medium (simulated gastric fluid (0.1 N HCL) was set at 37±0.2 ° C, and it took a while for the shot to break.

 

Dissolution Test:

USP type-1 (basket) 8-paddle accessories were used to break. Then, the tablets were placed in 900 ml of simulated gastric fluid (0.1 N HCl). The experimental state of dissolution has been retained, so that the temperature of moderate temperature was maintained in the rotation of the basket at 37±0.2 oC 150 rpm. After 10 ml After 2 ml The dissipation was carried out in the dissolution medium and the state of the synchronization was kept fresh (0.1 N HCl). This process was developed for one hour every 10 minutes. Reduction of samples by pipeline in 10 ml of fresh dissolution medium So that 10 ml Media have been filtered. UV Using spectroscopy at a maximum of 222 nm. According to USP [3], absorption is determined.
 

Assay:

To determine the difference between the actual quantity of active drugs and the quantity labeled, approximately 10 tablets of each brand and finely piped and 150 mg were taken. Like paracetamol, it is 200 ml of fine powder. Large amount of flask in 100 ml Distilled water and 50 ml 0.1 ml of sodium hydroxide was added and this mixture was sonicated up to 15 minutes, The solution was diluted after the volume and then 100 ml. 10 ml of filtration were transferred to volumetric flask and 100 ml. The solution was diluted after the volume and then 100 ml. 10 ml of filtration were transferred to volumetric flask and 100 ml. The UV spectrophotometer is a base line (200-400 nm) 0.1 m. The NaOH is ready to take up the absorption as an empty sample with solution. After analysis, the UV spectrophotometer was used for an empty solution of maximum λ of 257 nm and 0.1 m of NOAH. The same procedure was used to absorb pure drugs after 150 mg of pure medicinal substance (paracetamol), and it was observed that the exploitation was used to determine the percentile content of pure drugs in each brand. The rules of beer samples are determined according to BP [4] using the rules of lambart beer.
 

RESULTS AND DISCUSSION:

The results obtained through five different branded paracetamol tablets are met by the USP and BP Standers of IPQC exams.

 

Weight Variation:

The weight difference for more than 324 milligrams in official books is±5%. It was found from the evaluation that all the tablets did not have any of the brand tablets evaluated by±5% [12] without changing the weight of the USP. We can have a rough idea of ​​the uniformity of the content, but we can not confirm it with this test.
 

Friability:

This test of weakness provides ideas about parameters such as tenacity, resolution and resolution. There is a limit to weight reduction of more than 1.0% weight loss. This may depend on the nature of the materials used in the formulation and the nature of the materials. The eligibility of each brand is in the limit

 

Hardness:

Important parameter of hardness because in the pharmaceutical industry, because the tablet must survive during packaging and shipping. In addition, the tablet does not become too hard because the hardness is directly affected in the disintegration time, which may decrease the bioavailability [5]. The hardness should be in the limits of 4 kg/cm2 to 10 kg/cm2. The hardness of each brand tablet was within limits.
 

Disintegration Time:

Vighatanana time, helps determine the dissolution of the active ingredients through the production of the body's therapeutic efficacy and exploitation. This is the result of the interruption of the study received USP and BP [6] (Figure 2) within the particular appears as stardarda of the manuals, books or disintegration of time of 15 minutes. The results of the division test are given in the result (Table 2).

 

Assay:

Percentage of ingredients found through active substances of drugs, that is, paracetamol inspection method. All branded tablets show 100% ± 10% of the tag labeled with paracetamol content. According to the USP and BP paracetamol samples, they should not be more than 110% and less than 90% (Table 3).
 

DISSOLUTION:

The results of the test results obtained from each brand of paracetamol tablet are within the USP limit (NLT 80% 30 minutes) and BP (NLT 70% 30 minutes). Good results were obtained from each brand of paracetamol tablet 4). Therefore, the paracetamol-like medicine (preparation of analgesics and nervous system) relieves the patient of the pain of the medicine during the time of drug treatment [7] The medication is based on therapeutic treatment.
 

Table 1: Manufacturing date and expiry date of different paracetamol brands under test

Tablet Code

Manufacturing date

Expiry date

A

Des 2017

Nov 2020

B

 Jan 2018

Des 2021

C

Jan 2018

Des 2021

D

Feb 2018

Jan 2021

E

Nov 2017

Sept. 2020

 

Table 2: Comparative evaluation of different quality control parameters of paracetamol tablets

Tablet Code

Weight Variation %

Friability %

Hardness (kg/cm2 )

Disintegration Time (Min.)

A

0.7

0.33

4.3

2.2

B

1.5

0.54

4.2

3.1

C

0.9

0.59

4.5

3.4

D

1.3

0.52

4.0

2.1

E

1.2

0.48

4.5

2.7

 

Table 3: Result obtained for percent content of paracetamol tablets by UV method

Tablet Code

Concentration (mg/ml)

Absorbance

% Content

Content (mg)

A

0.000562

0.520

100.15

499.00

B

0.000660

0.502

85.40

495.00

C

0.000563

0.550

92.78

498.61

D

0.000655

0.512

89.80

492.13

E

0.000580

0.500

95.40

495.15

 

Table 4: Comparative evaluation of dissolution profile of paracetamol tablets

Time interval (Minutes)

% Release of Paracetamol content

A

B

C

D

E

10

75.55

75.60

72.90

57.00

64.40

20

89.54

88.30

87.60

67.55

75.60

30

90.10

95.60

96.00

76.40

83.50

40

96.51

93.12

97.22

87.50

95.80

50

95.70

90.63

99.30

94.30

92.11

60

92.30

93.45

94.00

92.87

89.90

 

 

Figure 2: disintegration time (Min.) of different brands of Tablet

 

Figure 3: assay of different brands of paracetamol tablets

 

Figure 4: dissolution profile of different brands of paracetamol tablet

 

CONCLUSION:

It has been concluded from the result that each brand tablet for benchmarking will give different results to each other, but the official books do not exceed the given limit.

 

ACKNOWLEDGEMENT:

Authors are highly Acknowledge the help of laboratory staff of Rajarambapu College of Pharmacy, Kasegaon. For providing necessary chemicals required for research work. Also we are highly Acknowledge the help and guidance of Dr. M. A. Bhutkar.

 

REFERENCES:

1.     Tripathi KD: Essential of Medicinal Pharmacology. Jaypee Brothers, Medical Publishers Ltd. Dehli, Fifth Edition.

2.     Palash Karmakar, Md. Golam Kibria: In-vitro comparative evaluation of quality control parameters between paracetamol and paracetamol/caffeine tablets available in Bangladesh. International Current Pharmaceutical Journal 2012; 1 (5):103-109.

3.     US Pharmacopoeia, The Official Compendia of Standards, 2, 2007, 1269- 90.

4.     British Pharmacopoeia, H. M. Stationary office, London, 3, 2008, 2968.

5.     US Pharmacopoeia, 28 (30-NF25), 2007, 618-690.

6.     L. Allen, Ansel’s Pharmaceutical Dosage form and Drug Delivery System. Lippincott Williams and Wilkins, Wolters Kluwer health, 9, 233.

7.     British Pharmacopoeia, UK London, Appendix IIB, 2007, 1678.

8.     Bamigbola, E.A., Ibrahim, M.A., Attama, A.A. 2009. Comparative in-vitro assessment of soluble and plain brands of aspirin tablets marketed in Nigeria, Sci Res Essays, 11 (4), 1412-1414.

 

 

 

 

 

Received on 28.08.2018                Accepted on 05.10.2018               

© Asian Pharma Press All Right Reserved

Asian J. Pharm. Tech.  2018; 8 (4):227-230.

DOI: 10.5958/2231-5713.2018.00035.1