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A NEW RP-HPLC METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULPHATE, THEOPHYLLINE AND FUROSEMIDE
July 16, 2025
The Importance of Simultaneous Analysis
- Patient Safety: Overlapping therapies for asthma and edema require strict monitoring to avoid under/over-dosing .
- Cost and Time Efficiency: Single-run analysis reduces reagent use and labor compared to multiple separate tests .
- Regulatory Compliance: Pharmacopeias increasingly demand multi-component assays for combination drugs .
Challenges in Existing Methods
Previous techniques faced limitations:
Spectrophotometry: Overlapping UV spectra of salbutamol, theophylline, and furosemide caused inaccuracies .
HPLC Drawbacks: Older methods had long retention times, narrow linear ranges, and sensitivity to pH fluctuations .
Costly Equipment: Mass spectrometry, while accurate, is prohibitively expensive for routine use .
Breakthroughs in the New RP-HPLC Method
The novel method optimizes critical parameters:
Mobile Phase: A blend of methanol (35%) and 0.02M Li₂SO₄ buffer (65%) ensures sharp peak separation. Lithium sulfate extends furosemide’s retention time without affecting other analytes .
Column Efficiency: A C18 column with 5µm particles enhances resolution and reduces run time to <15 minutes .
Validation Metrics:
- Linearity: 1–70 µg/mL (theophylline), 0.5–100 µg/mL (furosemide), and 5–150 µg/mL (salbutamol) .
- Recovery Rates: 96.7–99.5% for all drugs, meeting International Council for Harmonisation (ICH) guidelines .
- Precision: Intra-day and inter-day variability <5.5% .
Applications in Pharmaceutical Quality Control
- Batch Testing: Ensures consistency in combination tablets or syrups.
- Stability Studies: Monitors degradation under stress conditions (heat, light, humidity) .
- Bioequivalence Research: Facilitates comparisons between generic and branded formulations.
Data Tables
Table 1: Comparison of Analytical Methods
| Parameter | Spectrophotometry | Traditional HPLC | New RP-HPLC Method |
|---|---|---|---|
| Analysis Time | 30–60 min | 25–30 min | <15 min |
| Recovery (%) | 85–92 | 90–95 | 96.7–99.5 |
| Cost per Sample | $5 | $10 | $7 |
| Simultaneous | No | Partial | Yes |
Table 2: Validation Results for the New Method
| Drug | Linearity (µg/mL) | Precision (% RSD) | Recovery (%) |
|---|---|---|---|
| Salbutamol | 5–150 | 4.2 | 98.8 |
| Theophylline | 1–70 | 3.8 | 99.5 |
| Furosemide | 0.5–100 | 5.5 | 97.3 |
Table 3: Optimized Chromatographic Conditions
| Parameter | Specification |
|---|---|
| Column | C18 (250mm x 4.6mm, 5µm) |
| Mobile Phase | Methanol:0.02M Li₂SO₄ (35:65) |
| Flow Rate | 1.0 mL/min |
| Detection Wavelength | 254 nm |
| Injection Volume | 20 µL |
Conclusion: Paving the Way for Smarter Drug Analysis
This innovative RP-HPLC method bridges a critical gap in pharmaceutical testing, offering unparalleled accuracy and efficiency. By enabling simultaneous quantification of salbutamol, theophylline, and furosemide, it empowers manufacturers to maintain rigorous quality standards while reducing costs. As combination therapies become more prevalent, such advancements ensure safer, more reliable medications for patients worldwide.