STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VILDAGLIPTIN AND METFORMIN IN PHARMACEUTICAL DOSAGE FORM

Objective: The present study was aimed to develop a rapid, accurate, linear, sensitive and validate stability-indicating high performance liquid chromatographic [RP-HPLC] method for determination of vildagliptin and metformin in pharmaceutical dosage form.Methods: The chromatographic separation was performed on kromasil-C18 column [4.5 x 250 mm; 5 µm] using a mobile phase consisting of 0.05 mmol potassium dihydrogen phosphate buffer: acetonitrile [80:20 v/v], [pH adjusted to 3.5 using orthophosphoric acid]. The flow rate is 0.9 ml/min and the detection was carried out at 263 nm.Results: The chromatographic condition, the peak retention time of metformin and vildagliptin were found to be 2.215 min and 2.600 min respectively. Stress testing was performed in accordance with an international conference on harmonization [ICH] Q1A R2 guidelines. The method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 5-17.5 µg/ml and 50-175 µg/ml for vildagliptin and metformin. The limit of detection and quantification was found to be 0.0182 µg/ml and 0.0553 µg/ml for vildagliptin and 0.4451 µg/ml and 1.3490 µg/ml for metformin respectively.Conclusion: A new sensitive, simple and stability indicating reverse-phase high-performance liquid chromatography [RP-HPLC] method has been developed and validated for the determination of vildagliptin and metformin. The proposed method can be used for routine determination of vildagliptin and metformin

Feasibility of Oral Glucose Tolerance Test as a Diagnostic Tool for Diabetes Prevalence Study in a Rural Community

IntroductionDiabetes population is relentlessly increasing. This rise is substantially contributed by increasing prevalence in rural communities. We need to have prevalence studies in different communities to know the nature of the disease. For conducting diabetes prevalence studies, best test to rely upon is OGTT. This study was aimed to examine the feasibility of conducting OGTT in a rural community as a diagnostic tool in diabetes prevalence study.MethodsMeeting village leaders, arranging community gatherings and involving village representatives in health awareness program were the preparatory methods used in the study. Study team was trained to carry out various procedures involved. Every alternate person according to the electoral list was identified and reminded about his turn by repeated community announcements and meeting personally. Brief history, anthropometries were taken and OGTT was performed with 75 gram glucose load.Results Out of 341 participants invited, 326 consented and 318 completed the study. Eight participants did not turn up for second blood test but under went all other procedures. We conducted ten screening visits to complete the entire study procedures. The response rate for consenting and entering the study was 95.6% and that for completing the study was 93.2%. Out of 318 participants completed the study, 182 (57.2%) were females and 136 (42.7%) males. So total time spent for 10 screening visits was 70 hours. Total cost of the screening the village was 20,520 Indian rupees.ConclusionThe present study suggests that collecting OGTTs in rural communities is feasible. Committed research team, proper heath education, active involvement of the community members and long term association before starting the screening procedures results in better response rates

DIFFERENT ANALYTICAL TECHNIQUES FOR THE ANALYSIS OF ANTICANCER DRUGS-BOSUTINIB, ENCORAFENIB AND DABRAFENIB-A REVIEW

In this present situation there is an increase in the number of diseases has been observed but before this drug come to market, it must undergo several procedures. The validation and analytical methods are the important techniques that help in ensuring its purity and reliability. This process involves the use of various analytical techniques to collect data about the drug. This review includes various types of analytical techniques such as ultraviolet-visible Spectrophotometric and chromatography methods such as high-performance liquid chromatography, hyphenation techniques such as LC-MS for the estimation of selected anti-cancer drugs

A Validated HPTLC Densitometric Method for The Quantitative Determination of Ubidecarenone in Bulk and in Capsule Formulation

A new, simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the estimation of ubidecarenone in bulk and in capsule formulation. The chromatographic separation was performed on aluminium TLC plates precoated with silica gel 60F254 as a stationary phase and methanol:water (7:3) as a mobile phase. Detection was performed densitometrically in the absorbance mode at 280nm for the evaluation of chromatograms. The system has given well sharp peak of ubidecarenone (Rf=0.51±0.02). The linearity of the method was established in the range of 1-6 ng/µL with correlation coefficient (r2) of 0.9995. The method was validated for precision, accuracy, robustness, ruggedness, LOD, and LOQ as per ICH guidelines. The limit of detection was found to be 0.0392 ng/µL, whereas the limit of quantitation was found to be 0.1189 ng/µL. The percentage label claim for ubidecarenone in the capsule formulation was found to be 99.96±0.4703. The accuracy of the method was confirmed by recovery studies. The percentage recovery was found to be in the range of 100.10-101.45% for ubidecarenone. The % RSD value was found to be less than 2. The low %RSD value indicates that there is no interference due to excipients used in the formulation. Hence, the developed method was found to be simple, precise, accurate, and rapid for the analysis of ubidecarenone in bulk and pharmaceutical formulation and it can be effectively applied for the quality control analysis of ubidecarenone in bulk and pharmaceutical formulation

Simplified risk stratification criteria for identification of patients with MRSA bacteremia at low risk of infective endocarditis: implications for avoiding routine transesophageal echocardiography in MRSA bacteremia

The aim of this study was to identify patients with methicillin-resistant Staphylococcus aureus (MRSA) bacteremia with low risk of infective endocarditis (IE) who might not require routine trans-esophageal echocardiography (TEE). We retrospectively evaluated 398 patients presenting with MRSA bacteremia for the presence of the following clinical criteria: intravenous drug abuse (IVDA), long-term catheter, prolonged bacteremia, intra-cardiac device, prosthetic valve, hemodialysis dependency, vertebral/nonvertebral osteomyelitis, cardio-structural abnormality. IE was diagnosed using the modified Duke criteria. Of 398 patients with MRSA bacteremia, 26.4 % of cases were community-acquired, 56.3 % were health-care-associated, and 17.3 % were hospital-acquired. Of the group, 44 patients had definite IE, 119 had possible IE, and 235 had a rejected diagnosis. Out of 398 patients, 231 were evaluated with transthoracic echocardiography (TTE) or TEE. All 44 patients with definite IE fulfilled at least one criterion (sensitivity 100 %). Finally, a receiver operator characteristic (ROC) curve was obtained to evaluate the total risk score of our proposed criteria as a predictor of the presence of IE, and this was compared to the ROC curve of a previously proposed criteria. The area under the ROC curve for our criteria was 0.710, while the area under the ROC curve for the criteria previously proposed was 0.537 (p < 0.001). The p-value for comparing those 2 areas was less than 0.001, indicating statistical significance. Patients with MRSA bacteremia without any of our proposed clinical criteria have very low risk of developing IE and may not require routine TEE

Novel Selective Agents for the Degradation of Androgen Receptor Variants to Treat Castration-Resistant Prostate Cancer

Acknowledgements: The authors thank Mr. Maron Lee Barrett and Ms. Mayra Star for their technical help. The authors thank Dr. Dejian Ma for his technical help with the NMR studies. The authors thank the UTHSC and St. Jude NMR core for their help with the NMR studies. The authors thank Drs. Robert Getzenberg and Michael Mohler for providing useful comments on the manuscript. The authors thank Ms. Brandy Grimes for her help with tissue procurement. The authors thank Dr. Daniel Johnson of UT BioCore for microarray data analysis and Mr. Lorne Rose of UT-MRC core for microarray studies. Funding Source: The research presented in this manuscript was supported by a research funding provided by GTx, Inc. Memphis, TN to R. Narayanan and by a research funding provided by West Cancer Center to R. Narayanan.Peer reviewedPostprin

Assessment of trace metal contamination in a historical freshwater canal (Buckingham Canal), Chennai, India

The present study was done to assess the sources and the major processes controlling the trace metal distribution in sediments of Buckingham Canal. Based on the observed geochemical variations, the sediments are grouped as South Buckingham Canal and North Buckingham Canal sediments (SBC and NBC, respectively). SBC sediments show enrichment in Fe, Ti, Mn, Cr, V, Mo, and As concentrations, while NBC sediments show enrichment in Sn, Cu, Pb, Zn, Ni, and Hg. The calculated Chemical Index of Alteration and Chemical Index of Weathering values for all the sediments are relatively higher than the North American Shale Composite and Upper Continental Crust but similar to Post-Archaean Average Shale, and suggest a source area with moderate weathering. Overall, SBC sediments are highly enriched in Mo, Zn, Cu, and Hg (geoaccumulation index (Igeo) class 4– 6), whereas NBC sediments are enriched in Sn, Cu,Zn, and Hg (Igeo class 4–6). Cu, Ni, and Cr show higher than Effects-Range Median values and hence the biological adverse effect of these metals is 20%; Zn, which accounts for 50%, in the NBC sediments, has a more biological adverse effect than other metalsfound in these sediments. The calculated Igeo, Enrichment Factor, and Contamination Factor values indicate that Mo, Hg, Sn, Cu, and Zn are highly enriched in the Buckingham Canal sediments, suggesting the rapid urban and industrial development of Chennai MetropolitanCity have negatively influenced on the surrounding aquatic ecosystem

Palpable purpura with foot drop: Common presentations in an uncommon disease

Churg-Strauss syndrome is a rare disease manifested by hypereosinophilia, vasculitis and tissue infiltration. This report describes the case of a 45-year-old man who presented with a history of fever, difficulty in breathing, reddish lesions over the extremities and inability to walk since two weeks. The cutaneous features prompted us to conduct serial lab investigations which led to an early, potentially life saving diagnosis

Periimplant diseases : Etiopathogenesis and progression

Use of the implant-supported prosthesis has gained a strong foothold in oral rehabilitation in recent decades. The increasing number of implant restorations has necessitated their long-term maintenance for optimal health. The ubiquitous use of dental implants has been associated with the occurrence of implant failure, one of the most important causes being periimplant infections. Periimplant infection is a condition wherein clinical inflammation of periimplant soft tissue with or without periimplant bone loss is evident. Knowledge of etiology alone determines the treatment and long-term maintenance of implants and periimplant tissue. There is a spate of scientific data exploring the etiologic factors resulting in periimplant infection. In this article, an earnest effort is made to analyze and present contemporary research data