SIMULTANEOUS QUANTIFICATION OF BUPRENORPHINE HCL AND NALOXONE HCL BY VIERORDT'S METHOD
Objective: Development of a simple, rapid and accurate vierordt's method or simultaneous equation (SE) method for the simultaneous estimation of Buprenorphine HCl (BU) and Naloxone HCl (NA) in bulk and pharmaceutical dosage form. The proposed method was validated according to the guidelines of the International Conference on Harmonization and the Association of Official Analytical Chemists International.
Methods: The method was based on the measurement of absorbance at two wavelengths 289.0 nm and 283.8 nm, Î»max of BU and NA in methanol respectively.
Results: Calibration curves were linear in the concentration range of 40-200 Âµg ml-1 for BU and 40-260 Âµg ml-1 for NA. The mean recovery, limit of quantification (LOQ) and limit of detection (LOD) for BU were 98.91 %, 0.481 Âµg ml-1 and 0.158 Âµg ml-1 and for NA were 98.85 %, 1.283 Âµg ml-1 and 0.423 Âµg ml-1, respectively. The method was precise, with a relative standard deviation of less than 2.0 % for both drugs. For robustness, the factors analyzed did not significantly affect the quantification of BU and NA.
Conclusion: The proposed method can be successfully applied for simultaneous estimation of BU and NA in bulk and pharmaceutical dosage form.
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