Abstract
A simple, economic and time-efficient stability-indicating, reverse-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for analysis of silver lactate in the presence of degradation products generated by decomposition. When silver lactate was subjected to acid hydrolysis, base hydrolysis, oxidative, photolytic, humidity and thermal stress, degradation was observed during base hydrolysis, oxidation, humidity and thermal stress. The drug was found to be stable to other stress conditions. Successful chromatographic condition of the drug from the degradation products formed under stress conditions was achieved on a phenomenex Gemini column with potassium dihydrogen phosphate buffer, pH adjusted to 2.2 with orthophosphoric acid, as mobile phase. The method was validated for linearity, precision, specificity and robustness and can be used for quality-control during manufacture and assessment of the stability of samples of silver lactate. To the best of our knowledge, a validated stability-indicating LC assay method for silver lactate based on lactic acid is reported for the first time.
Highlights
Silver lactate chemically 2-hydroxypropanoic acid silver salt[1] has the molecular formula C3H5AgO3 and molecular weight 196.94
This paper describes a simple isocratic reverse-phase HPLC method that separates silver, lactic acid and degradation products
This paper reports, for the first time, a rapid, efficient, simple and validated stability-indicating reversephase high-performance liquid chromatographic (RP-HPLC) method for assay of silver lactate
Summary
Silver lactate chemically 2-hydroxypropanoic acid silver salt[1] has the molecular formula C3H5AgO3 and molecular weight 196.94. This paper describes a simple isocratic reverse-phase HPLC method that separates silver, lactic acid and degradation products. Assay of silver lactate is calculated based on the lactic acid peak. This paper reports, for the first time, a rapid, efficient, simple and validated stability-indicating RP-HPLC method for assay of silver lactate. Assay studies of stressed samples were performed by comparison with lactic acid reference standard. The precision of the method was assessed by performing six independent assays of silver lactate test sample (15 mg mL-1) in comparison with lactic acid reference standard (7 mg mL-1) and calculating the RSD (%) of the assay. The solution stability of silver lactate in the assay method was carried out by leaving test solutions of sample and reference standard in water in tightly capped volumetric flasks at room temperature for 24 h.
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