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

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-

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-

Table 2:   Analytical method development using UV- spectroscopy

Table 3: Analytical method development using HPLC method

Table 4: Analytical Method Development Using HPTLC Method