Stability-indicating LC method for the simultaneous determination of methyl paraben, propyl paraben, butylated hydroxytoluene and alpha-tocopherol contents in marijuana capsules

Abstract

The current study is a simple liquid chromatographic method developed and validated for the simultaneous determination of methyl paraben, propyl paraben, butylated hydroxytoluene and alpha-tocopherol in marijuana (delta-8-tetra hydro cannabinol (or) dronabinol) soft gelatin capsules by using high-performance liquid chromatographic technique. The chromatographic separation was achieved on a Waters Xterra RP18 (150 × 4.6)-mm 5-µm column with a mobile phase contained gradient mixtures, which constitutes of purified water and acetonitrile in the ratio of 700:300 (Port-A) and acetonitrile (Port-B). The optimized flow rate of 2.0 mL/min and UV detection was made at 210 nm and column temperature of 40 °C. The resolution among MP, PP, BHT and ATP was found to be > 4. The optimized method was validated as per the guidelines prescribed by the international conference on harmonization. Regression analysis confers a correlation coefficient higher than 0.999 for MP, PP, BHT and ATP peaks. The % RSD for the interday and intraday precisions for MP, PP, BHT and ATP was estimated and found to be < 5.0. The proposed HPLC method could be suitable for the estimation of these drugs in different types of pharmaceutical drug products. Schematic diagram of the procedure for the simultaneous determination of MP, PP, BHT and ATP contents in marijuana capsules