Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TOLPERISONE AND PARACETAMOL IN BULK DOSAGE FORMS

Snehal Santosh Maskar* and R. S. Bandal

Abstract

To guarantee the precision and dependability of analytical techniques used to ascertain the concentration of active pharmaceutical ingredients (APIs) in compounded dosage forms, method development is a methodical and crucial procedure. These techniques' reproducibility and suitability for producing data for submission are established through validation, which also guarantees adherence to legal criteria. The analytical assessment of two commonly used pharmaceutical substances, tolperisone and paracetamol, is the main emphasis of this work. A common analgesic and antipyretic, paracetamol is mostly used to treat mild to moderate fever and pain. Conversely, tolperisone, a derivative of piperidine, functions as a centrally acting muscle relaxant and is widely used to treat neurological disorders that cause elevated muscle tone, such as multiple sclerosis, myelopathy, encephalomyelitis, spastic paralysis, and pyramidal tract damage. These medications work in concert to provide a synergistic therapeutic impact in the treatment of muscle spasms and pain. This review looks at different analytical techniques for identifying tolperisone and paracetamol in pharmaceutical formulations and biological samples. There is discussion of methods like liquid chromatography-mass spectrometry (LC-MS), high-performance thin-layer chromatography (HPTLC), highperformance liquid chromatography (HPLC), and spectrophotometry. The study highlights the advantages and disadvantages of different techniques by assessing them according to their sensitivity, accuracy, and suitability for pharmaceutical investigation.

Keywords: Paracetamol, Tolperisone, analytical methods, muscle relaxant, HPLC, pharmaceutical analysis.