Department of Pharmaceutical Chemistry Pataldhamal Wadhwani College of Pharmacy, Yavatmal (M.S.)
A simple, precise, and accurate high-performance liquid chromatographic (HPLC) method was developed and validated for the simultaneous estimation of Phenylephrine hydrochloride, Paracetamol, and Chlorpheniramine maleate in a combined tablet dosage form. Chromatographic separation was achieved using a [specify column, e.g., C18] column with a mobile phase consisting of [specify solvents, e.g., phosphate buffer and acetonitrile] in a suitable ratio under isocratic conditions. The flow rate was maintained at [e.g., 1.0 mL/min], and detection was carried out using a UV detector at a wavelength of [e.g., 265 nm]. The retention times of Phenylephrine, Paracetamol, and Chlorpheniramine were found to be well resolved with acceptable resolution. The method was validated according to ICH guidelines for linearity, accuracy, precision, specificity, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves were linear over the concentration ranges suitable for routine quality control. The method demonstrated excellent recovery rates and low relative standard deviation values, indicating good reproducibility. The developed HPLC method is suitable for routine analysis of these drugs in pharmaceutical formulations without interference from excipients.
Analytical chemistry is a vital sub-discipline of chemistry concerned with the qualitative and quantitative analysis of matter. It serves as the foundation for many scientific investigations and industrial processes by providing essential information about the chemical composition, structure, and quantity of substances. The importance of analytical chemistry extends across numerous fields including environmental monitoring, medicine, pharmaceuticals, forensic science, food safety, and materials engineering. Its applications are evident in everyday life, from detecting contaminants in drinking water to ensuring the purity of pharmaceutical products. The evolution of analytical chemistry has been marked by significant technological advancements. Historically, classical methods such as gravimetric and titrimetric analyses were widely used to determine the presence and amount of chemical species. While these methods are still relevant and valuable for certain applications, the increasing demand for higher sensitivity, selectivity, and speed has led to the development of modern instrumental techniques. These include spectroscopic methods (such as UV-Vis, IR, and atomic absorption spectrometry), chromatographic techniques (such as gas chromatography and high-performance liquid chromatography), and advanced mass spectrometry systems. Each of these methods offers unique advantages and can be tailored to specific analytical requirements. A key aspect of analytical chemistry is its emphasis on accuracy, precision, sensitivity, and reproducibility. Modern analytical techniques are not only capable of detecting trace levels of analytes but also provide robust data that can be used for regulatory compliance and scientific research. Furthermore, the integration of analytical instruments with computational tools and data analysis software has enhanced the capability to interpret complex data sets and make informed decisions based on chemical evidence. In recent years, the scope of analytical chemistry has expanded to address global challenges such as environmental pollution, climate change, and public health threats. For instance, analytical methods are employed to monitor air and water quality, detect harmful chemicals in food products, and track the spread of pathogens. Additionally, the rise of green analytical chemistry promotes the development of eco-friendly methods that reduce the use of hazardous substances and energy consumption, aligning with broader sustainability goals. This research paper aims to provide an overview of the principles and methodologies of analytical chemistry, with a focus on modern instrumental techniques. It will also explore how these techniques are applied in various industries and research fields, demonstrating the indispensable role of analytical chemistry in advancing scientific knowledge and improving the quality of life.
DRUG PROFILE:
Paracetamol
|
Chemical name |
N-(4-hydroxyphenyl) ethanamide N-(hydroxyphenyl)acetamid |
|
Description |
white or almost white, crystalline powder |
|
Molecular formula |
C8H9NO2 |
|
Mode of action |
Paracetamol The main mechanism proposed is the inhibition of cyclooxygenase (COX), and recent findings suggest that it is highly selective for COX-2 |
|
Molecular weight |
51.17 g/mol |
|
Melting point |
169 °C |
|
Dose |
500 mg |
|
pKa |
9.38 |
|
Solubility |
Soluble in water, Acetonitrile and methanol. |
|
Category |
analgesic and antipyretic |
Phenylephrine hydrochloride
|
Chemical name |
3-[(1R)-1-hydroxy-2-(methylamino)ethyl] phenol; hydrochloride |
|
Description |
White to off white crystalline powder |
|
Molecular formula |
C9H13NO2.CIH |
|
Mode of action |
Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. |
|
Molecular weight |
203.66 g/mol |
|
Melting point |
284-293 °C |
|
Dose |
10 mg |
|
pKa |
6.76-6.98 |
|
Solubility |
Freely soluble in in methanol. |
|
Category |
Adrenergic alpha-1 receptor agonist |
Chlorphenamine maleate
|
Chemical name |
(Z)-but-2-enedioic acid;3-(4-chlorophenyl)-N, N-dimethyl-3-pyridin-2- ylpropan-1-amine |
|
Description |
White or almost white, amorphous powder |
|
Molecular formula |
C16H19CIN2.C4H4O4 |
|
Mode of action |
Blocks H1-receptor sites and prevents the action of histamine on the cell. |
|
Molecular weight |
390.9 g/mol |
|
Melting point |
266 to 275 °C |
|
Dose |
400 mg |
|
pKa |
9.47 |
|
Solubility |
Sparingly soluble in water and freely soluble in ethanol. |
|
Category |
For relief of rhinorrhea, sneezing, lacrimation, itching eyes, oro nasopharyngeal itching, and/or other symptoms. |
EXPERIMENTAL WORK
The study involved the use of three active pharmaceutical ingredients (APIs): Paracetamol, Phenylephrine HCl, and Chlorpheniramine Maleate, all obtained from Yarrow Chem, Mumbai, with purities above 99.8%. The marketed formulation "Febrex Plus" was used as the reference sample. Analytical reagents were of AR and HPLC grade, including methanol, acetonitrile, and orthophosphoric acid. Key instruments included a UV-Visible Spectrophotometer, HPLC system with PDA detector, pH meter, analytical balance, and ultrasonicator. Functional group analysis of the APIs was performed using Infrared Spectroscopy via the KBr pellet method. The IR spectra of the samples matched their respective reference spectra, confirming the identity and purity of the drugs.
Instruments:
|
Sr. No |
Instrument |
Make |
Model |
|
1 |
UV-Visible Spectrophotometer |
Thermo Electron Shimadzu |
Double beam carry-07 Bio UV 1601 |
|
2 |
HPLC |
Waters 600 |
PDA Detector |
|
3 |
pH Meter |
Hanna |
- |
|
4 |
Balance |
Citizen |
CY 104 (Micro Analytical Balance) |
|
5 |
Ultrasonicator |
- |
1.5 L 50 |
RESULTS AND DISCUSSION
A reliable RP-HPLC method was developed and validated for the simultaneous estimation of Phenylephrine (PHE), Paracetamol (PAR), and Chlorpheniramine Maleate (CPM) in a tablet formulation (Febrex Plus). The method utilized a Phenomenex C18 column with a mobile phase of 0.1% orthophosphoric acid and methanol (70:30 v/v), at a flow rate of 1.0 mL/min, and detection at 240 nm. The method produced well-resolved peaks with suitable retention times (PHE: 2.48 min, PAR: 3.83 min, CPM: 9.11 min) and acceptable system suitability parameters such as theoretical plates (>2000), tailing factor (<2), and %RSD (<2%). Assay results of the marketed formulation were within acceptable limits: PHE (99.68%), PAR (99.4%), and CPM (100.2%). Validation confirmed the method's precision, accuracy (99–101% recovery), linearity (R² > 0.98), specificity, and robustness against minor variations in flow, mobile phase composition, and detection wavelength. In conclusion, the developed RP-HPLC method is simple, accurate, and robust, making it suitable for routine quality control of this triple-drug formulation.
CONCLUSION
From the studies it can be concluded that RP-HPLC technique can be successfully used for the estimation of the Phenylephrine, Paracetamol and Chlorpheniramine maleate in their combined dosage tablet formulations. The method shows good reproducibility to the RP-HPLC method is accurate, precise, specific, reproducible and sensitive. The analysis of combined dose formulation of Phenylephrine, Paracetamol and Chlorpheniramine maleate can also be successfully performed by the RP-HPLC method. The RP-HPLC method is also simple, accurate, precise, reproducible, economical and rapid too. It may be adopted for routine control analysis of these three drugs in combined dosage form. No interference of additives, matrix etc. is encountered in these methods. Further studies on other pharmaceutical formulations would throw more light on these studies. Suitability of these methods on biological samples also needs study.
REFERENCES
Gaurav Vairagade*, Dr. A. P. Dewani, Development and Validation of High-Performance Liquid Chromatographic Method for Analysis of Phenylephrine, Paracetamol and Chlorpheniramine Maleate in A Tablet Dosage Form, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 5, 3217-3222. https://doi.org/10.5281/zenodo.15463733
10.5281/zenodo.15463733
