UPLC analysis of keto-analogues of essential amino acid calcium salt

Alpha keto-analogues of valine, leucine, isoleucine, methionine, phenyl-alanine, and (in one instance) tryptophan and histidine, along with the remaining essential amino acids, are used to treat severe renal failure (Chronic Uremia). Mixtures of the salts are useful in the treatment of renal and hepatic disorders characterized by protein intolerance leading to deficiencies of various essential and semi-essential amino acids in the body. The analytical method for determination of calcium salts of some alpha keto acid analogues using ultra performance liquid chromatography was developed and validated as per the ICH guideline in terms of Specificity, Linearity and range, Accuracy, Precision, Limit of Detection, Limit of Quantification, Robustness and Stability. The method has been proved as a high throughput screening as it has analysis time of only 8.0 minutes with very good sensitivity and resolution; this method is applicable for bulk drug as well as in pharmaceutical dosage form