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Author(s): Ramniwas1, Komal Gupta2, Ankita Gupta3, Aakanksha Sinha4, S.J. Daharwal*5

Email(s): 1, 2, 3, 4, 5daharwalresearch@rediffmail.com

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    1University Institute of Pharmacy Pt. Ravishankar Shukla University Raipur, Chhattisgarh, India
    2University Institute of Pharmacy Pt. Ravishankar Shukla University Raipur, Chhattisgarh, India
    3University Institute of Pharmacy Pt. Ravishankar Shukla University Raipur, Chhattisgarh, India
    4University Institute of Pharmacy Pt. Ravishankar Shukla University Raipur, Chhattisgarh, India
    5University Institute of Pharmacy Pt. Ravishankar Shukla University Raipur, Chhattisgarh, India
    *Corresponding Author Email- daharwalresearch@rediffmail.com

Published In:   Volume - 4,      Issue - 2,     Year - 2022


Cite this article:
Ramniwas, Komal Gupta, Ankita Gupta, Aakanksha Sinha and S.J. Daharwal (2022) A Review on various analytical methodology for Ondansetron. NewBioWorld A Journal of Alumni Association of Biotechnology,4(2):18-24.

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 NewBioWorld A Journal of Alumni Association of Biotechnology (2022) 4(2):18-24            

REVIEW ARTICLE

A Review on various analytical methodology for Ondansetron

Ramniwas, Komal Gupta, Ankita Gupta, Aakanksha Sinha and S.J. Daharwal*

 

University Institute of Pharmacy Pt. Ravishankar Shukla University Raipur, Chhattisgarh, India

*Corresponding Author Email- daharwalresearch@rediffmail.com

ARTICLE INFORMATION

 

ABSTRACT

Article history:

Received

28 September 2022

Received in revised form

19 October 2022

Accepted

27 October 2022

Keywords:

Ondansetron;

Analytical;

HPLC;

UV Spectroscopy;

HPTLC

 

The antiemetic drug ondansetron is used to treat nausea and vomiting. the creation of a straight forward, quick, affordable, accurate, and exact approach that has been approved for the estimation of ondansetron in pharmaceutical dose form and bulk form.  Whether ondansetron is being estimated in pharmaceutical dose form or in bulk, the current study mostly focuses on analytical methodologies and a few tested methods. Since they enable us to employ cutting-edge analytical equipment to collect both qualitative and quantitative data, analytical methods are crucial for determining compositions. These methods aid in comprehending critical process factors and reducing the detrimental influence they have on accuracy and precision. Analytical technique development is required to uphold strict commercial product quality standards and to comply with regulatory constraints. To maintain high commercial product quality standards and to adhere to norms and regulations, analytical technique development is necessary. Regulatory organizations have created policies and procedures for granting authorization, authentication, and registration in response to the reference.

 


1. Introduction

Ondansetron was developed by Glaxo Smith Kline in 1980 and was given FDA approval in 1991. This vital antiemetic medication is used to treat nausea and vomiting. The medication is available as an intravenous injection, syrup, mouth dissolving tablet, oral tablet, and capsule. The gastrointestinal tract is where ondansetron is absorbed, and only a little amount of first-pass metabolism occurs. It is a highly specialised and selective antagonist of the serotonin 5-HT3 receptor. Serotonin (5-HT) is released by enterochromaffin cells of the small intestine in response to cytotoxic chemotherapy and radiotherapy, perhaps causing vomiting. response by triggering the 5-HT3 receptors on the vagal afferents. Ondansetron may prevent the reflex from starting. A central release of serotonin from the region postrema's chemoreceptor trigger zone (Tramèr et al. 1997), which is found on the fourth ventricle's floor, may also result from the activation of vagal afferents. utilised to reduce vomiting and nausea by lowering vagus nerve activity at the postrema chemoreceptor trigger zone. IUPAC Name: 9-[(2-methylimidazol-1-yl)methyl]-3-[methyl]C18H19N3O is the chemical formula for the compound -2, 3-dihydro-1H-carbazol-4-one (Tanveer et al. 2021).

1.1 Physicochemical properties of ondansetron-

DOI: 10.52228/NBW-JAAB.2022-4-2-4

Ondansetron has the molecular formula C18H19N3O, is found as crystals, and has a melting point between 231-232 °C. Ondansetron has a low solubility in distilled water, a moderate solubility in acetate buffer, a moderate solubility in a hydrochloric acid buffer with a pH of 2.8, and a moderate solubility in ethanol (Suknuntha et al. 2022).

Figure 1:  Structure of Ondansetron

1.2 Pharmacokinetics-

The gastrointestinal tract is where ondansetron is absorbed, and only a little amount of first-pass metabolism occurs. In comparison to the 8 mg tablet, the 16 mg tablets AUC was 24% greater. Ondansetron is a substrate of human hepatic cytochrome P450 enzymes, including CYP1A2 and CYP2D6, according to investigations on its in vitro metabolism. Ondansetron has been distributed in an amount of 160L, according to records. Ondansetron is substantially metabolized after being either orally or intravenously, and it is then eliminated in the urine and faeces. Ondansetron clearance values in healthy adult volunteers aged 19 to 40. Ondansetron has a half-life of about 3–4 hours, while it can last up to 6–8 hours in elderly patients (Roila et al.1995).

1.3 Pharmacodynamics-   

The serotonin 5-HT3 receptors are found centrally in the region postrema's chemoreceptor trigger zone and peripherally on the vagus nerve terminals. Serotonin is believed to be released from the enterochromaffin cells of the small intestine by chemotherapeutic agents by inducing GI tract degeneration, according to the temporal relationship between the emetogenic action of emetogenic drugs and the release of serotonin as well as the effectiveness of antiemetic medications. Serotonin activates the 5-HT3 receptors in the postrema region and the vagal and splanchnic nerve receptors that project to the medullary vomiting centre, triggering the vomiting reflex and resulting in nausea and vomiting (Huddart et al. 2019). Negative outcomes are the most frequently reported side effects include constipation, malaise, dry mouth, headaches, and dry mouth. Local injection site reactions, pruritus, and central nervous system (CNS) symptoms like weariness and drowsiness are among other less common adverse effects. Pimozide and ondansetron shouldn't be given at the same time since QTc prolongation can occur. Administration of amiodarone together with ondansetron necessitates monitoring because it may also cause the QTc interval to prolong. Serotonin syndrome may occur if ondansetron is taken with other serotonergic medications (Stevens et al. 2017).

2.  Need of analytical method

For the quality and development of formulations, quality assurance and quality control departments in the pharmaceutical industry require analytically developed methods. New analytical methods are more in demand because they are better at analyzing and developing the good activity of drugs. The improved method also reduces analysis time while increasing precision, accuracy, and analysis cost. The analysis tools used in these procedures are essential for generating reliable and high-quality data. These techniques could be electrochemical, chromatographic, hyphenated, spectroscopic, or other. The creation of analytical techniques helps to reduce the impact of key process variables on precision and accuracy and to better understand them. Analytical methods should be created utilizing the relevant procedures and requirements specified in the ICH recommendations when following GMP and GLP regulations. Q2 (R1). The process of choosing an exact assay technique to determine the composition of a formulation is known as the analytical method, which is sometimes referred to as the analytical approach. Analytical instrumentation must be carefully chosen in order to develop a novel analytical process. Range, accuracy, precision, linearity, limits of detection and quantitation (LOD), and specificity must all be considered while developing a process (Ravisankar et al. 2014).

3. Analytical Method Development by UV Spectroscopy: -

An analytical method called UV spectroscopy counts the discrete wavelengths of UV or visible light that a sample absorbs or transmits in comparison to a control sample. Ultraviolet-visible spectroscopy is the study of interactions between materials and electromagnetic radiation in this range. The ultraviolet region has three wavelength ranges: UV-A (320-400 nm), UV-B (290-320 nm), and UV-C (200-290 nm). According to the Beer- Lambert Law, a solution's absorbance and its path length are exactly proportional to one another. In order to be able to utilise it to determine the absorbance in a solution for a specific path length (Anthony et al. 1993). A tungsten or halogen lamp is frequently used for visible light in devices with two lights. Monochromators, absorption filters, interference filters, cutoff filters, and band pass filters are some of the available techniques (USP 2000). Examples of a few of those are given in Table no. 2.

4. Analytical method development by HPLC

High performance liquid chromatography (HPLC) is by far the most widely used sepration method and one of the most well-established analytical processes. Using a liquid mobile phase, the components of a combination can be separated using HPLC. A good silica and bonding method will result in a repeatable and symmetrical peak, which is necessary for accurate certification. Commonly utilized RP columns include C18 (USP L1), C8 (USP L8), phenyl (USP L11), and cyno (USP L18). It is an analytical instrument that can identify, classify, and quantify the drug, as well as its different contaminants and drug-related degradation products that may occur during manufacture or storage. The basic principle of HPLC in normal phase and reverse phase mode is adsorption. The sample is introduced into HPLC column, different components of the sample move according to their affinities towards the stationary phase (Gupta et al. 2012, Sahu et al. 2018). Examples of a few of those are given in Table no. 3.

5. Analytical Method Development Using HPTLC Method

High performance thin layer chromatography HPTLC is an automated form of thin layer chromatography TLC based on separation of molecules by absorption. HPTLC include phytochemical and biomedical analysis, herbal drug quantification, active ingredient quantification, fingerprinting of formulations, and check for adulterants in the formulations.  Selection of mobile phase is based on adsorbent material used as stationary phase and physical and chemical properties of analyte. It has increased reproducibility for quality control of herbal products by using standardized methods and system suitability tests for the qualification of the plates. HPTLC fingerprinting: Simplifying quality control, a single HPTLC study provides information on the identification, purity, and content of an herbal drug, preparation, or product (Patel et al. 2010). Examples of a few of those are given in Table no. 4.


 

Table 1: Ondansetron brand name along with drug formulation-

Drug Formulation

Concentration

Route of administration

Brand Name

Tablet

8 mg

Orally

Zofran

Injection

2 mg

Intravenously

Ondansetron injection-BP

Syrup

2 mg/5 ml

Orally

Vomikind

Solution

4 mg/5 ml

Orally

Ondansetron

Oral suspension

1 mg/5 ml

Orally

R-Ondansetron

Mouth dissolving tablet

4 mg

Sublingual

Ondet

Oral drops

2 mg/5 ml

Orally

Zonda

Capsule

4/20 mg

Orally

OND-R

 

Table 2:   Analytical method development using UV- spectroscopy

S. No.

Sample

Method

Solvent

Wavelength

Linearity

Accuracy

Precision

LOD

LOQ

Reference

1

Tablet

Simultaneously equation method

0.1 N HCL

261 nm

5-25 µg/ml

-

1.48

1.187 µg/ml

3.596

(Patra et al. 2017)

2

Tablet

Q- absorbance ratio method

Methanol

260.6 nm

100-450 µg/ml

100.3

0.25

1.65 µg/ml

5 µg/ml

(Raza et al. 2007)

4

Bulk and ointment

1st order derivatives method (3092 double beam)

10% v/v Ethanol

224.19 nm

17.5-32.5 µg/ml

99.89± 0.79

-

-

-

(Ravi Kumar et al. 2006)

5

Tablet

1st derivative spectra

0.01 M NaOH

246.0 nm

2-6 µg/ml

0.596± 0.0008

-

-

-

(Prasad et al. 1989)

 

 


Table 3: Analytical method development using HPLC method

S. No.

Dosage form

Stationary phase

Mobile phase

Wave-length

Flow rate

RT

linearity

Accuracy

(%)

Precision

(%)

LOD

LOQ

 

 

Reference

1

Tablet

IP

Column 25×4.6 mm

20:80 Acetonitrile and potassium phosphate buffer solution respectively

216 nm

1.5 ml/min

1.0 min

-

-

-

-

-

(IP 2014)

2

Tablet in bulk

C18 column (250 mm×4.6 mm id, 5µ particle size)

Buffer: acetonitrile: Methanol (50: 40: 10 % v /v/v) (pH 4.5±0.05)

249 nm

1.0 ml/min

2.67± 0.05 min.

0.9982

100.45

<2

1.005

3.046

(Deshmukh et al. 2015)

3

Tablet

C18 (250 mm×4.6 mm, id 5µ particle size

50mm potassium dihydrogen orthophosphate: acetonitrile (pH 6, ratio 60: 40 v/v)

 

222 nm

 

 

1.0 ml/min

6.4 min

0.992

-

0.70-1.82

-

-

(Meyyanathan et al. 2012)

4

Injectables

Inertsil ODS 150×4.6 mm column with 3

70% KH 2 PO 4 20 mm with triethylammonium phosphate and 30% acetonitrile

 

216 nm

 

1.5 ml/min

<2 min.

-

˂2

˂2

-

-

(Balint et al. 2018)

 

5

Tablet

C 18, 5µm, column (250×4.6mm)

methanol: Acetonitrile: Potassium hydrogen ortho phosphate buffer pH 3 (40:20:40 v/v)

210 nm

 

1 ml/min

2.7 - 4.1 min

0.999

98-105

1.5

0.075

0.232

(Rakam et al. 2022)

 

 

 

Table 4: Analytical Method Development Using HPTLC Method

S. No.

method

Sample

Stationary phase

Mobile phase

Wave length

Rf

Linearity

Accuracy

Precision

LOD

LOQ

Reference

1

HPTLC

Tablet

silica gel 60 F 254

Dichloromethane: Methanol (9:1)

309 nm

0.54± 0.03

100-500 ng/spot

-

-

99

302.8

(Raval et al. 2008)

2

HPTLC

Tablet

silica gel 60 F 254

Chloroform: methanol: ethyl acetate (7:2:1 v/v).

302nm

0.67± 0.011

-

-

-

4.9

14.7

(Saraya et al. 2008)

3

HPTLC

Tablet

 silica gel 60 F 254

toluene: methanol: acetone (6:2:2.5, v/v/v)

286 nm

0.53

-

-

1.035

5.029

15.239

(Khatal et al. 2014)

4

HPTLC

Tablet in Bulk

silica gel 60 F254

Chloroform: ethyl acetate: methanol: ammonia (9:5:4:0.1)

254 nm

0.52± 0.02

0.9952

-

-

14.83

44.92

(Mujtaba et al. 2013)


Conclusion

This review article is based on the literature survey of the Estimation of ondansetron with their various dosage form like tablet syrup injection by HPTLC, HPLC, UV spectroscopy which include information regarding the drug ondansetron and its analytical estimation through HPTLC, HPLC AND UV Spectroscopy. This analytical data is useful for the development of new analytical method.  The result of the article to give more information about the drug ondansetron with the various analytical method uses for the estimation of the drugs.

References

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