DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL, DICLOFENAC POTASSIUM AND CHLORZOXAZONE IN BULK DRUG AND TABLET DOSAGE FORM

摘要

Objective: Research study was undertaken to develop and validate simple, rapid, precise, accurate, robust High Performance Thin Layer Chromatographic (HPTLC) method for simultaneous determination of paracetamol (PARA), diclofenac potassium (DCL) and chlorzoxazone (CHL) in bulk drug and tablet dosage form. Methods: The chromatographic separation was performed on precoated silica gel G 60 F254plates with toluene: ethyl acetate [55:45, v/v] as mobile phase. The detection was carried out at 271 nm. Results: Retention factors of PARA, DCL and CHL were found to be 0.21 ± 0.01, 0.54 ± 0.01, and 0.74 ± 0.01, respectively. Linearity of PARA, DCL and CHL was found to be in the concentration range of 1000-3500 ng band-1, 100-350 ng band-1 and 500-1750 ng band-1, respectively. The % assay (Mean ± S.D.) was found to be 100.63 % ± 1.2, 103.46 ± 1.58 and 101.85 % ± 1.92 for PARA, DCL and CHL, respectively. Method was validated for linearity, accuracy, precision, specificity, robustness in accordance with International Conference on Harmonisation [ICH] guidelines. Conclusion: The proposed HPTLC method has been successfully applied for the analysis of drugs in tablet dosage formulation and applicable to routine analysis PARA, DCL and CHL in bulk drug and tablet dosage form