SIMPLE COST EFFECTIVE, ECO FRIENDLY METHOD DEVELOPMENT FOR THE ESTIMATION METHADONE HYDROCHLORIDE IN MARKETED FORMULATION
Pradeep Kumar Yadav
ABSTRACT
A simple, cost-effective, and eco-friendly UV spectrophotometric method was developed and validated for the quantitative estimation of Methadone Hydrochloride in marketed tablet formulations. The method is based on the measurement of absorbance at 239.0 nm using an environmentally benign solvent system, minimizing solvent consumption and analytical waste. Linearity was established in the concentration range of 5–25 µg/mL, with an excellent correlation coefficient (r² = 0.9994). The proposed method was validated as per ICH Q2 (R1) guidelines for accuracy, precision, and assay. Recovery studies at 80%, 100%, and 120% levels showed mean recoveries ranging from 98.62% to 99.21%, confirming the accuracy of the method. Precision studies demonstrated low %RSD values, indicating good repeatability, intermediate precision, and reproducibility. The assay of the marketed tablet formulation revealed 99.00% of the label claim, confirming the suitability of the method for routine quality control analysis. Owing to its simplicity, low cost, and environmental friendliness, the developed method is recommended for routine estimation of Methadone hydrochloride in pharmaceutical dosage forms.
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