Abstract:The quantification of copper in water, vegetables, foodstuffs, human hair and pharmaceutical samples was determined by a simple more sensitive and selective spectrophotometric method. Cu(II) forms an orange -red color complex with 5-{ά -methyl-3-hydroxy benzylidene} rhodanine [5M, 3H-BR], at pH 5.5 in sodium acetate and acetic acid buffer. The maximum absorbance was measured at 430 nm. The Beer's law is obeyed in the range of (0.05 µg -13 µg/mL). The molar absorptivity (ε) and the Sandell's sensitivity of the complex were 0.6027× 10 4 mol -1 cm -1 and 0.01054 µg cm -2 respectively. First, second and third derivative spectrophotometry were also proposed and employed successfully for the determination of copper in the supra. The performance of the present method was also evaluated in terms of RMSEP, REP and RSD, students t-test. This indicates the greater importance of the method than other methods reported in the literature.

New stability-indicating RP-UPLC technique was developed for the quantification of ertugliflozin and metformin  in human plasma and validated as per the regulatory guidelines. Both the drug components and internal standard were spiked to blank plasma and subjected to liquid-liquid extraction with the mobile phase. The resultant solution was infused into Acquity BEH-C18 (1.7 μ, 100×2.1mm) non-polar column comprising NaH2PO4  buffer (pH-3.5), methanol and acetonitrile in the ratio of 50:10:40% v/v/v  as mobile phase. The detector response and flow of the mobile phase were monitored at 240nm and 0.5ml/min, respectively. The linearity plot was made in the concentration range of 0.1-3.0 µg/ml for metformin and 0.05-1.5 µg/ml for ertugliflozin with correlation coefficient value of more than 0.999. The developed method was subjected for bench-top, freeze and thaw, long-term and short-term stability studies and the drug components were stable over the respective conditions. The Lower limit of quantification (LLOQ) for ertugliflozin and metformin  were 0.05 and 0.1 µg/ml, respectively. The findings of precision and accuracy were present in between 2.6 to 4.2 %RSD and -2 to 3.99 %RE, respectively. The findings of the stability data were presented below. The %stability of ertugliflozin and metformin  were varying from 96% to 104% for ertugliflozin and 96% to 105% for metformin.

Present investigation is based upon a new method development and validation for the simultaneous estimation of drugs comes under the classification of anti-hypertensive and anti-diabetic. For the proposed method metformin, ivabradine, metoprolol and ertugliflozin drugs were selected. The chromatographic separation was achieved by using mobile phase 0.01N potassium dihydrogen ortho phosphate buffer and acetonitrile (50:50) ratio and stationary phase of kromasil C18(250×4.6mm, 5µm) column. The retention times for metformin, ivabradine, metoprolol and ertugliflozin were found to be 2.560min, 3.116 min, 3.473 min and 5.196 min respectively. The developed method shows that all the drugs were clearly separated among each other with the system suitability. The developed method was further validated as per ICH guidelines Q2R1. It was found the method was accurate, presice with good linearity. Hence this method can be used for the routine analysis of these drugs in biological sample.

Context: The focus of this review is to compile the different chromatographic methods that were reported earlier for the analysis of different antihypertensive and antidiabetic drugs. Objective: The magnitude of chemical entities investigated and entering into the medicinal field for various health-related ailments is escalating year after year. The drugs are either innovative entities or fractional structural variation of the preexisting chemical molecule. These drugs may exhibit unexpected toxicities after Phase IV of clinical trials, resulting in their withdrawal from the market. Under these circumstances, analytical measures for these drugs may not be accessible in the pharmacopeias. The main aim of this work is to compile the different analytical techniques for the quantification of various antihypertensive drugs and antidiabetic drugs. Methods: The present work is to thoroughly study the literature for the application of different analytical techniques such as high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectroscopy/tandem mass spectroscopy (LC-MS/MS) for the quantification of antihypertensive drugs and anti-diabetic drugs. Results: The present study attempts to collate various analytical techniques that were developed and validated for the estimation of few important antidiabetic and antihypertensive drugs either in pure, individually or combined with other pharmaceutical dosage form by HPLC, LC-MS/MS, and high-performance thin-layer chromatography techniques. Conclusion: Different chromatographic methods are considered to be rapid tools for qualitative and quantitative analysis of newer chemical entities in pharmaceuticals. The amount of these newer chemical entities which are reaching the pharmaceutical market is increasing day by day nevertheless there exists a lag in establishing the standard protocols for the identification, impurity profiling, related substance and assay method. Hence, the present review compiles the different analytical methods that were reported in the literature and thus helps the researchers and chemists to make use of the analytical techniques for the quantification and validation of various antidiabetic and antihypertensive drugs.

This study explains about the Analytical Quality by Design approach for the optimization of a High-Performance Liquid Chromatography Method for the simultaneous estimation of Metformin and Ertugliflozin in pharmaceutical substance. The study aimed to optimize the High-Performance Liquid Chromatography (HPLC) by means of an analytical target profile in order to achieve good separation of compounds along with acceptable analysis time. Identification of risk factors for variables affects the method efficacy. This leads to the development of an accurate, precise, and economic method. The optimized conditions of the developed method were a stationary phase of a Discovery C18 250 x 4.6mm, 5m and a mobile phase of Orthophosphoric acid buffer (pH 2.2),ACN taken in the ratio 60:40 was selected as mobile phase and detection wavelength of 230nm. The flow rate was selected as 0.98ml/min at 29.150C column temperature. Using the central composite design (CCD) method was optimized. The method is showing the linearity over the concentration range of 25-150µg/ml for Metformin and 0.375-2.25µg/ml for Ertugliflozin. The intra-and inter-day precision were less than 2% of relative standard deviation. Accuracies between  99-102% of the true values.The LOD obtained for Metformin and Ertugliflozin were found to be 59 and 3.7, respectively.  LOQ obtained for Metformin and Ertugliflozin were 77.6 and 5.2, respectively.Under accelerated conditionsdegradation percentage of the drug was found to be less than 10%, and the degradation product peak not affecting the system suitability of Metformin and Ertugliflozin.