Abstract
A simple, precise, specific and accurate high performance thin layer chromatographic method has been developed for the simultaneous determination of Tapentadol Hydrochloride (TAPE) and Paracetamol (PCM) in pharmaceutical dosage form. The separation was carried out on Merck HPTLC aluminum plates of silica gel G60 F254, (20 × 10 cm) with 250 μm thickness using chloroform: toluene: methanol: glacial acetic acid (6: 2: 1.5: 0.5, v/v/v/v) as mobile phase. HPTLC separation of the two drugs followed by densitometric measurement was carried out in the absorbance mode at 274 nm. The drugs were resolved satisfactorily with Rf values of 0.25 ± 0.01 and 0.55 ± 0.01 for TAPE and PCM, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with R2 value 0.9982 and 0.9964 for TAPE and PCM, respectively in the concentration range of 50 - 250 ng/spot for TAPE and 325 - 1625 ng ng/spot for PCM. The method was validated for accuracy, precision, specificity and robustness. The limit of detection and quantitation were 0.5067 and 1.5355 ng/spot, respectively for TAPE and 0.5706 and 1.7456 ng/spot, respectively for PCM. The proposed developed HPTLC method can be applied for identification and quantitative determination of TAPE and PCM in bulk drug and drug formulation.