Stability Indicating and Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin in Tablet dosage form using RP-HPLC

Aim: To Perform Simultaneous Determination of Saxagliptin, Dapagliflozin and Metformin Tablet dosage form developed in a simple, Accurate, precise manner. Method: Agilent C18 150 x 4.6mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 50:50 was pumped through column at a flow rate of 1.0 ml/min used for the development of chromatogram. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 260nm. Results and Conclusion: Retention time of Saxagliptin, Dapagliflozin and Metformin were found to be 2.253 min, 2.720 min, 3.276 min respectively. % RSD of the Saxagliptin, Dapagliflozin and Metformin were and found to be 0.8, 0.2 and 0.6. % Recovery was obtained as 99.60%, 100.07% and 99.95% for Saxagliptin, Dapagliflozin and Metformin respectively. LOD, LOQ values obtained from regression equations of Saxagliptin, Dapagliflozin and Metformin were 0.06, 0.12, 9.61 and 0.17, 0.36, 29.31 respectively. Regression equation of Saxagliptin is y = 40882x + 889.2, Dapagliflozin is y = 47904x + 3897 and Metformin is y = 4530.x + 35785. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Development and validation of new analytical method for the simultaneous estimation of Netupitant and Palonosetron in bulk and pharmaceutical dosage form

A simple, Accurate, precise method was developed for the simultaneous estimation of the Netupitant and Palonosetron in pharmaceutical dosage form. Retention time of Palonosetron and Netupitant were found to be 2.266 min and 2.805 min. %RSD of the Netupitant and Palonosetron were and found to be 0.8 and 1.1 respectively. %Recovery was obtained as 100.08% and 100.15% for Netupitant and Palonosetron respectively. LOD, LOQ values obtained from regression equations of Netupitant and Palonosetron were 1.63, 4.94 and 0.003, 0.010. respectively. Regression equation of Netupitant is y =11553x + 9661.and y = 51072x + 152.0. of Palonosetron. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Development and validation of new analytical method for the simultaneous estimation of daunorubicin and cytarabine in bulk and pharmaceutical dosage form

A simple, Accurate, precise method was developed for the simultaneous estimation of the Daunorubicin and Cytarabine inhalation dosage form. Chromatogram was run through BDS C18 150 x 4.6 mm, 5m. Mobile phase containing 0.1% OPA: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 240nm. Retention time of Daunorubicin and Cytarabine were found to be 2.245 min and 2.813. %RSD of the Daunorubicin and Cytarabine were and found to be 0.6and 0.3 respectively. %Recovery was obtained as 99.39% and 99.26% for Daunorubicin and Cytarabine respectively. LOD, LOQ values obtained from regression equations of Daunorubicin and Cytarabine were 0.03, 0.10 and 0.31, 0.94 respectively. Regression equation of Daunorubicin is y = 2677x + 703.5, y = 2524x + 104.7 of Cytarabine.Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Risk Analysis by a Probabilistic Model of the Measurement Process

The aim of the article is presentation of the testing methodology and results of examination the probabilistic model of the measurement process. The case study concerns the determination of the risk of an incorrect decision in the assessment of the compliance of products by measurement. Measurand is characterized by the generalized Rayleigh distribution. The model of the measurement process was tested in parallel mode by six risk metrics. An undesirable effect in the reconstruction building block of the model was detected, consisting in the distortion of probability distribution at the edges of the measuring range. The paper gives guidelines on how to use the model, to obtain the analytical risk assessment consistent with the results of the Monte Carlo method. The study can be useful in product quality control, test design, and fault diagnosis.

Survey of Mean Glandular Dose to Patients During Mammography Examinations: A Retrospective Study

The radiation dose delivered to patients undergoing mammography examination is of utmost importance because of the risk of cancer induction due to the process. In this work, we analyze the dose to 109 patients (214 images) who underwent mammographic examinations with a full-field digital mammography (FFDM) system. Quality control assessment was first performed using the International Atomic Energy Agency (IAEA) Human Health Series 2 and 17 protocol and the European guidelines for quality assurance in breast cancer screening and diagnosis. The results from the quality control test performed indicates that the system is functioning well. The mean glandular dose of patients analyzed shows that 23 out of 109 patients received averaged doses higher than the acceptable level at the same equivalent breast thickness of a phantom. The mammography system at the department is recommended for continuous use for imaging and screening of patients.

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-UPLC METHOD FOR THE QUANTIFICATION OF BALOXAVIR MARBOXIL IN TABLET FORMULATION

Objective: Aim of the present work is to develop a simple, accurate and precise stability-indicating method for the quantification of baloxavir marboxil (BLMX) in tablet dosage form by UPLC. Methods: Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8 mm) reverse phase column and the mobile phase composition of buffer 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 was processed through a column at a flow rate of 0.3 ml/min. Column oven temperature was maintained at 30 °C and the detection wavelength was processed at 240 nm. Results: Retention time of BLMX was found to be 0.87 min. Repeatability of the method was determined in the form of %RSD and the value was 0.2. The percentage mean recovery of the method was found to be 99.47%. LOD, LOQ values obtained from the regression equation of BLMX were 0.69 and 2.10 mg/ml, respectively. Regression equation and correlation coefficient values of BLMX were y = 16994x+7179.2 and 0.9996. Drug was subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 5.96% and 9.55%. Conclusion: Retention time and total run time of the drug was decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of BLMX.