HPLC Method Development, Validation, and Forced Degradation for Simultaneous Analysis of Oxycodone and Naltrexonein Pharmaceutical Dosage Form

Abstract

A simple, precise and stability-indicating RP-HPLC method was developed for simultaneous quantification of oxycodone (OXCD) and naltrexone (NTRX) in combined dosage form. The developed method was validated with respect to precision, linearity, accuracy, robustness, ruggedness, sensitivity and solution stability. The method was developed with ammonium di hydrogen phosphate buffer (pH 5.0) and acetonitrile in a ratio of 55:45 (v/v) as mobile phase at a flow rate of 1.0 mL/minute over Intersil ODS C18 column (250 mm × 4.6 mm×5μ).The UV detection wavelength was fixed at 235 nm. The column temperature was maintained at ambient temperature. The method showed good linearity with correlation coefficient values of 0.9990 and 0.9994 for OXCD and NTRX. The percent recoveries of the two drugs found within the limits of 98.0–102.0%. The LOQ concentrations of OXCD and NTRX are 0.625 μg/ mL and 0.075 μg/mL, respectively. The LOD concentrations of OXCD and NTRX are 0.3125 μg/mL and 0.0375 μg/mL, respectively. According to ICH guidelines forced degradation study was validated.

Generation of predictive models for oxidative degradation kinetics of dapagliflozin with the applications of DOE and stability indicating HPLC method

“…DGZ blocks this transporter mechanism and allows blood sugar to be eliminated through the urine. [1][2][3] UV-Visible spectrophotometric [4][5][6][7][8][9] and liquid chromatographic methods [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] are reported in the literature for the analysis of DGZ in various samples. Three UV-Visible spectrophotometric methods [4][5][6] for estimation of DGZ in bulk and pharmaceutical dosage forms, two UV-Visible F I G U R E 1 Chemical structure of Dapagliflozin spectrophotometric methods 7,8 for simultaneous estimation of DGZ, and Metformin in the synthetic mixture and one UV-Visible spectrophotometric method 9 for estimation of DGZ and Saxagliptin in rat serum have been described.…”

“…In addition, four reverse phase liquid chromatographic methods [10][11][12]28 for estimation of DGZ, three reverse phase liquid chromatographic methods [13][14][15] for estimation of DGZ and Metformin in combination and one method for estimation of DGZ and Saxagliptin 16 in bulk and tablet dosage forms are reported. Furthermore, stability indicating HPLC methods [17][18][19] for estimation of DGZ, four stability indicating HPLC methods [20][21][22]29 for simultaneous estimation of DGZ and Metformin, and five stability indicating HPLC methods [23][24][25][26][27] for simultaneous estimation of DGZ and Saxagliptin are also found in the literature.…”

“…UV–Visible spectrophotometric 4–9 and liquid chromatographic methods 10–29 are reported in the literature for the analysis of DGZ in various samples. Three UV–Visible spectrophotometric methods 4–6 for estimation of DGZ in bulk and pharmaceutical dosage forms, two UV–Visible spectrophotometric methods 7,8 for simultaneous estimation of DGZ, and Metformin in the synthetic mixture and one UV–Visible spectrophotometric method 9 for estimation of DGZ and Saxagliptin in rat serum have been described.…”