Dr.M.Sumithra

Verified @gmail.com

Associate Professor/Department of Pharmaceutical Chemistry and Analysis
School of Pharmaceutical Sciences,VISTAS,Chennai,603001



           

https://researchid.co/m.sumithra
28

Scopus Publications

Scopus Publications

  • Stability Indicating and Green Solvent-Assisted Chromatographic Analysis of an Antiviral Drug
    K. Archana and M. Sumithra
    Springer Science and Business Media LLC

  • Development and Validation of a Bioanalytical Method to Determine Empagliflozin in Human Plasma Using UPLC-MS/MS
    Mani Sumithra, David John Andrew, and Muthukumar Vijey Aanandhi
    MANUSCRIPT TECHNOMEDIA LLP
    Aim: The study we are conducting aims to establish a validated method for measuring empagliflozin in plasma using UPLC MS/MS. Materials and Methods: Sodium-Glucose co Transporter inhibitors (SGLTi), a novel class of diabetes medication. Non-insulin dependent diabetes and adult-onset diabetes were the prior names for type 2 diabetes. Empagliflozin was the first SGLT2-inhibitor a drug used that reduced the risk of cardiovascular risk those with type 2 diabetes and pre-existing cardiovascular disease. The empagliflozin D4 as Internal Solution (IS). Liquid-liquid extraction was used to achieve separation on Synergi 2.5µ Fusion-Reverse phase 100A (100 mm×2.0 mm), 2.5 µm column. Mixture of Methanol: As a mobile phase, 0.2% formic acid in a 75:25 volumetric ratio is utilised. The flow rate is set at 0.3µl/min. The calibration curve is linear and plotted. Results: The developed method is accurate, precise, sensitive method for determination of empagliflozin from human plasma solution. Ethyl acetate and water in HPLC grade are preferred solvent for empagliflozin. Performing LLE extraction with centrifuge and LV Nitrogen Evaporator it with Ethyl acetate and water. Ethyl acetate is used as non-polar solvent and water is used as polar solvent for liquid-liquid extraction. LLE is a low cost extraction process compare to solid liquid extraction. The reported method is suitable for bioequivalence and pharmacokinetic studies.

  • Computational investigation of four isoquinoline alkaloids against polycystic ovarian syndrome
    Murali Krishna Moka, Ankul Singh S., and Sumithra M.
    Informa UK Limited
    Abstract Hyperandrogenism, insulin resistance, and estrogen dominance are the prime defining traits of women with polycystic ovarian syndrome which disrupts hormonal, adrenal, or ovarian functions resulting in impaired folliculogenesis and excess androgen production. The purpose of this study is to identify an appropriate bioactive antagonistic ligand from isoquinoline alkaloids [palmatine (PAL), jatrorrhizine (JAT), magnoflorine (MAG) and berberine (BBR)] from stems of Tinospora cordifolia. Phytocomponents inhibit/prevent androgenic, estrogenic, and steroidogenic receptors, insulin binding, and resultant hyperandrogenism. Intending to develop new inhibitors for human androgen receptor (1E3G), insulin receptor (3EKK), estrogen receptor beta (1U3S), and human steroidogenic cytochromeP450 17A1 (6WR0), here we report the docking studies by employing a flexible ligand docking approach using AutodockVina 4.2.6. ADMET screened swissADME and toxicological predictions to identify novel and potent inhibitors against PCOS. Binding affinity was obtained using Schrodinger. Two ligands, mainly BER (−8.23) and PAL (−6.71) showed the best docking score against androgen receptors. A molecular docking study reveals that compounds BBR and PAL were found to be tight binder at the active site of IE3G. Molecular dynamics results suggest that BBR and PAL showed good binding stability of active site residues. The present study corroborates the molecular dynamics of the compound BBR and PAL, potent Inhibitors of IE3G, having therapeutic potential for PCOS. We project that this study’s findings will be helpful in drug development efforts targeting PCOS. Hence isoquinoline alkaloids (BER& PAL) have potential roles against androgen receptors, and in specific PCOS, scientific evaluation has been put forth based on virtual screening. Communicated by Ramaswamy H. Sarma


  • Insights into Novel Therapeutic Targets and Molecular Aspects in Polycystic Ovarian Syndrome: A Review
    Rukaiah Fatma Begum, M. Sumithra, V. Chitra, and Sharmila Devi
    Office of Academic Resources, Chulalongkorn University - DIGITAL COMMONS JOURNALS



  • QbD Based Development and Validation of RP-HPLC Method for Nintedanib Esylate: Application to Bioanalytical and Stability Study in Plasma
    Santosh. A. Waghmare and M. Sumithra
    Informa UK Limited
    Abstract The objective of this experiment was to develop and validate a simple, robust, and accurate Reverse- Phase High-Performance Liquid Chromatography method for estimation of Nintedanib Esylate in bulk, Pharmaceutical Dosage form, and Human Plasma. Full 3 Level Factorial design was employed for optimizing columns C8 and C18. The optimized chromatographic conditions are column C18, Ammonium format buffer: Acetonitrile (28.19:71.81 v/v) and pH of buffer (3). Furthermore, acetonitrile was used as a precipitating agent to extract Nintedanib in human plasma. After centrifuging at 2000 rpm, the supernatant was then injected and observed that the peak from blank plasma does not interfere with the peak of Nintedanib by using p-nitrophenol as an internal standard. Linearity was observed in the concentration range of 10 µg to 50 µg/mL (r2=0.9988). The accuracy range was 99.87 to 100.08 %. Intra-day and Inter-day precision was found to be 0.5432 & 0.5242 (% RSD). The bioanalytical method was validated as per ICH guideline M10 and results were found to be r2 (0.9988), Recovery (99.91 %), Specificity (99.94 %), Precision (Less than 0.543 % RSD), and Robustness (less than 0.500 % RSD. The proposed method was useful for the best analysis of Nintedanib Esylate in Bulk, pharmaceutical dosage forms and was successfully applied to a pharmacokinetic study.


  • Phytochemical analysis of seed of medicinal herb, Areca Catechu Linn. And evaluation of in-vitro anthelmintic activity of arecoline in aqueous and organic extracts


  • Novel anticoagulants beyond heparin and warfarin
    Akbar Basha S and Abdul Kareem S
    Innovare Academic Sciences Pvt Ltd
    Objective: The objective of the study is to know about newer anticoagulant drugs.Method: The Vitamin K adversaries are the single type of oral anticoagulant in the pharmaceutical, and which is endorsed for long-haul utilize.What is more, the Vitamin K adversaries are exceedingly successful, so it is utilized to avert, and treatment of most thrombotic infections in patients,the noteworthy interpatient and intrapatient are additionally fluctuation in measurement response, and the thin restorative medication record andthe more quantities of medication and dietary communications related with these specialists have lead clinicians, patients, and examiners to scanfor different operators. The three new orally controlled anticoagulants are apixaban, dabigatran, and rivaroxaban, which are in the late periods ofprogression and a couple of others they are basically entering (or traveling through), the earlier times of examinations. Those most recent anticoagulantdrugs are being contemplated just for the avoidance and furthermore the treatment of venous for the thromboembolism, and the treatment of intensecoronary conduit disorders, and furthermore the counteractive action of stroke in patients influenced by atrial fibrillation.Results: The pharmacological action of the three new orally controlled anticoagulants is apixaban, dabigatran, and rivaroxaban completely reviewedand compared with warfarin.Conclusion: We are compared the newer anticoagulant with warfarin and discussed about advantages of newer anticoagulants.

  • Green approaches in sample preparation for the estimation of atenolol, aspirin, atorvastatin calcium and losartan potassium in bulk and its pharmaceutical dosage form prior to chromatographic technique
    M. Sumithra and V. Ravichandiran
    Modestum Publishing Ltd
    Objective: A multivariate statistics method, simple, economical and eco friendly method for simultaneous estimation of Atenolol, Aspirin, Atorvastatin and Losartan potassium in bulk and its Pharmaceutical dosage form using liquid chromatographic method. Method: The method has been developed by using C18 column (250 • 4.6 mm, 5 lm) with UV detection at 237 nm. The developed method optimized by using Quality by design (QbD) technique and Derringer’s desirability function was applied. The sample solution is prepared by using dispersive liquid –liquid extraction (DLLME). Results: Central Composite Design was used to study the effect of independent factors. Derringer’s desirability function was applied to simultaneously optimize the retention time of last eluting peak (Atorvastatin calcium), capacity factor and resolution between Aspirin and Losartan potasium. The optimized method was validated according to ICH guidelines. The another important aspect is DLLME that the method uses microlitre amounts of organic solvent, produces low levels of waste and minimizing effluent treatment, which contributes to the environment and implements methods aimed green chemistry, making economic and environment safe for the people. Conclusion: The method can be employed as an alternative in quality control routine analysis of pharmaceutical industry for quantification of Atenolol, Aspirin, Atorvastatin and Losartan potassium in bulk and its Pharmaceutical dosage form using liquid chromatographic method.

  • Determination of chromatographic assay and validation of ofloxacin in bulk and pharmaceutical dosage form
    Sumithra M
    Innovare Academic Sciences Pvt Ltd
    Objective: The objective of the study is simple, sensitive; eco-friendly reverse phase chromatographic method has been developed and validated for the quantitative determination of ofloxacin in bulk and marketed formulation. Method: The developed method was done using Hypersil silica C18 (250 mm × 4.6 mm, 5 μ particle size) as column and the mobile phase is containing water and methanol in the ratio of (10:90) vol/vol. The mobile phase pass at 1 ml/min flow rate and the eluted solution is measured at 270 nm using a PDA detector. Results: The assay method is linear from the concentration range of 5–30 μg/ml. The corelation coefficient is 0.9998. The mean percentage recovery for the developed method is found to be in the range of 98.4–100.6%. The developed method complies robustness studies. Conclusion: The validation of the developed method was done by as per the ICH guidelines. It obeys the linearity, accuracy, precision, and robustness studies. Validation parameters are within the limitations. The results of the developed process indicated the reverse phase chromatographic method is simple, accurate as well as precise, rapid and eco-friendly method for routine analysis of ofloxacin in bulk and its pharmaceutical dosage form.

  • AQbD oriented new LC-ESI/MS method for quantification of sirolimus in drug and spiked plasma sample
    Mani Sumithra, Velayutham Ravichandiran, and Palani Shanmugasundarm
    Bentham Science Publishers Ltd.

  • A prospective study to compare insulin and insulin analogs in type II diabetic patients
    Gireesha Ks and Sumithra M
    Innovare Academic Sciences Pvt Ltd
    Objective: To compare the safety and quality of life of insulin and insulin analogues in Type II Diabetic patients.Methods: 100 patients who are diagnosed with type – II diabetes milletus are taken.In these 50 patients are of insulin analogues and 50 patients are of conventional insulin The safety was based on number of hypoglycemic events.Data was collected by using the EQ-5D questionnaire and EQ Visual Analogue scale (EQ-VAS) to assess the quality of life from the patient.Result:The percentage of the patients who had hypoglycemic events in conventional insulin group is 54% (n=27) and insulin analogues group is 20% (n=10). Mean score points of QOL obtained by conventional insulin patients is 75.9 and by insulin analogues patients is 93.75Conclusion: Insulin analogues group has low risk of hypoglycaemia when compared with the conventional insulin.The patient group who are in No problem category are found to have better QOL. The safety and QOL statistical differences constitute less likely among insulin and insulin analogues. The use of insulin analogues will continue to advance our efforts at improving diabetes care and treated related adverse outcomes can be reduced.

  • A study on the errors with intravenous administration of drugs in a tertiary care hospital
    M. Sumithra, P. Saranya, and D. Yashwitaa
    A and V Publications
    The aim of the study is to monitor and observe the incidence of intravenous drug administration errors in the general medicine department of a tertiary care hospital. Preparation and administration of the intravenous drugs to in-patients of the general medicine department was monitored by direct observational method. In a total of 329 intravenous administrations, 54.71% of errors were observed in the patient population out of which 74.78% showed at least one error. The results revealed that the flow rate error 45% were more prevalent among the overall study population followed by reconstitution error 26%, wrong mix errors were found to be 23% and incompatibility were found to be 10%. Errors were observed in both intravenous infusions as well as in intravenous bolus injections. Since intravenous administration of drugs have advantages of quicker delivery of drug to the target site via blood, proper care should be taken by nurses and other health care professionals in the IV drug administration. Errors can be minimized by utilising advanced techniques like small infusion smart pumps and automated flow rate infusion set.

  • Stress degradation studies and development of validated spectrometric- assay-method for determination of tofacitinib in pure and physical admixtures
    A.S.K. Sankar, P. Shanmugasundaram, B. Datchayani, N. Balakumaran, Mohammed Rilwan, R. Subaranjani, and M. Sumithra
    A and V Publications
    Aim:The aim is to develop simple validated analytical method for analysis of Tofacitinib by UV Spectroscopy and to study the forced degradation and stress conditions have been used to detect the stability of Tofacitinib. Method: Tofacitinib was estimated at 285.9nm. Linearity range was found to be 10-50 mcg/ml. The correlation coefficient was found to be 0.9996. The molar absorptivity was found to be 12468.77mol/cm. The proposed method Sandell’s sensitivity was found to be 0.040410 µg cm2/0.001AU. The limit of detection and quantification were found to be 0.8169 and 2.4755 µg/ ml respectively. The degradation behavior of Tofacitinib was carried out as per the standard procedures and guidelines. Forced acid hydrolytic degradation, alkali degradation and oxidative degradation of was performed in bulk Tofacitinib and laboratory prepared admixtures using 1M Hydrochloric acid up to 48 hrs, in 10 % Hydrogen peroxide up to 48 hrs and for 1.0 M Sodium hydroxide up to 10 min at room temperature. The resulting solutions were analyzed for content by UV spectrophotometry at the maximum absorption of 285.9 n. The assay value of Tofacitinib in bulk and physical admixture was calculated at different time intervals for intraday and interday experiments. Results and Conclusions: The proposed method was successfully applied for the determination of tofacitinib in pure and laboratory prepared physical mixtures. The % RSD value of Tofacitinib in bulk and physical admixture was calculated at different time intervals for recovery , precision (Iintraday and Interday experiments) and quantification studies were found to be less than 2 %.

  • A prospective study of drug utilization and evaluation of gastro intestinal agents
    M. Sumithra and Avantika Prabhabanik
    A and V Publications
    OBJECTIVE:A study was conducted to evaluate drug utilization of gastrointestinal agents in pediatric and geriatric patients. METHODS: Randomly selected 150 patients of gastrointestinal diseases with 92 male and 58 female of age from 15-58 underwent drug utilization evaluation of gastrointestinal agents. The frequencies of gastrointestinal agents were calculated and compared WHO indicators of DUS (drug utilization study) guidelines. RESULTS: Results include patients on long term gastrointestinal drug therapy on geriartric patient, paediatric patient. It include 92 male and 58 female patients in which 38.66% of female patient was and 61.335 of male patient suffered from gastrointestinal diseases. Out of 150 patients21.33% of patients was treated with pantoprazole,12% of patients was treated with esomeprazole ,28.66% of patients was treated with omeprazole,10.66% of patients was treated with rabeprazole,27.33% of patients was treated with ranitidine. Oral route of administration was more than parenteral administration. Gastritis is occurred more than inflammatory bowel disease, peptic ulcer disease and gastroesophageal reflux disease

  • Quality by design-based optimization and validation of new reverse phase-high-performance liquid chromatography method for simultaneous estimation of levofloxacin hemihydrate and ambroxol hydrochloride in bulk and its pharmaceutical dosage form
    Sumithra Sumithra, Shanmugasundaram P, and Ravichandiran V
    Innovare Academic Sciences Pvt Ltd
    ABSTRACTObjective: Innovative application of quality by design (QbD) technique for simultaneous estimation of levofloxacin and ambroxol hydrochloride (HCL)in bulk and its pharmaceutical dosage form using reverse phase-high-performance liquid chromatography (RP-HPLC) method.Method: A method has been developed for the separation of levofloxacin and ambroxol HCL using RP-HPLC on C18 column (250 4.6 mm, 5 ml) withultraviolet detection at 306 nm. Experimental designs were applied for multivariate optimization of the experimental conditions of RP-HPLC method.Three independent factors: Acetonitrile content in the mobile phase composition, buffer pH, and flow rate were used to design mathematical models.Here, central composite design (CCD) experimental design was used to study the response surface technique and to study in depth the effects ofthese independent factors. Derringer’s desirability function was applied to simultaneously optimize the retention time of last eluting peak (ambroxolhydrochloride) and resolution between levofloxacin and ambroxol hydrochloride.Result and Discussion: The predicted optimum assay condition consisted of acetonitrile, potassium dihydrogen phosphate buffer (pH 5.00;potassium dihydrogen phosphate), and methanol in a proportion of 20:70:10% v/v, respectively, as the mobile phase at a flow rate of 1.2 ml/minute.Using this optimum condition, baseline separation of both drugs with good resolution and a run time of <5 minutes were achieved. The optimizedassay condition was validated according to the ICH guidelines to confirm specificity, linearity, accuracy, and precision.Keywords: Levofloxacin, Ambroxol hydrochloride, Experimental design, Response surface methodology, Derringer’s desirability, Quality by designapproach.

  • Analyitcal method development and validation of a reversed-phase high-performance liquid chromatography for the determination of modafinil in bulk and pharmaceutical dosage forms
    Bijithra Cholaraja, Shanmugasundaram P, Ragan G, Sankar Ask, and Sumithra M
    Innovare Academic Sciences Pvt Ltd
    ABSTRACTObjective: To development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) for the determination of modafinilin bulk and pharmaceutical dosage forms.Methods: A simple, precise, rapid, and accurate RP-HPLC method was developed for the estimation of modafinil in bulk and pharmaceutical dosageforms. Xterra RP 18 (250 mm × 4.6 mm, 5 µ particle size) with a mobile phase consisting of methanol:water 70:30 V/V was used. The flow rate1.0 ml/min and the effluents were monitored at 260 nm. The retention time and recovery time was 12 minutes. The detector response was linear inthe concentration of 10-50 µg/ml. The respective linear regression equation being Y=452.1x+65237. The limit of detection and limit of quantificationwere 4.547 and 1.377 mcg, respectively. The method was validated by determining its accuracy, precision, and system suitability.Result: The objective of the present work is to develop simple, precise, and reliable HPLC method for the analysis of modafinil in bulk andpharmaceutical dosage forms. This is achieved using the most commonly employed Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size) columndetection at 260 nm. The present method was validated according to ICH guidelines.Conclusion: In this study, a simple, fast and reliable HPLC method was developed and validated for the determination of modafinil in pharmaceuticalformulations.Keywords: Modafinil, Reversed-phase high-performance liquid chromatography, Estimation, ICH guidelines, Tablets. 

  • Analytical method development and validation of ambroxol hydrochloride by uv spectroscopy and forced degradation study and detection of stability
    M. Sumithra, P. Yuvanesh, and Anamika Mistry
    A and V Publications
    Aim: The aim is to develop simple validated analytical method for analysis of Ambroxol hydrochloride by UV Spectroscopy and to study the forced degradation and stress conditions have been used to detect the stability of Ambroxol hydrochloride. Method: Ambroxol hydrochloride was estimated at 306nm. Linearity range was found to be2-10mcg/ml. The correlation coefficient was found to be 0.99987. The molar absorptivity was found to be 3947 L mol/cm. The proposed method Sandell’s sensitivity was found to be 0.111111 µg cm-2/0.001AU. The limit of detection and limit of quantification were found to be 3.94210and 11.94577µg /ml respectively. The degradation behavior of Ambroxol hydrochloride was carried out as per the standard procedures and guidelines. Forced acid hydrolytic degradation, alkali degradation and oxidative degradation of Ambroxol hydrochloride was performed in bulk and solid oral formulation using 1N Hydrochloric acid and 0.1M Sodium hydroxide at room temperature in different time intervals such as 0mins,30mins, 60mins and 90mins. The resulting solutions were analyzed for content by UV spectrophotometry at the maximum absorption of 306 nm.. The assay value ofAmbroxol hydrochloride in bulk and formulation was calculated at different time intervals for intraday and interday experiments. Results and conclusion: The proposed method was successfully applied for the determination of Ambroxol hydrochloride in bulk and Pharmaceutical formulations (Tablets). The results were demonstrated, that the procedure is accurate, precise and reproducible (relative standard deviation < 2%), For acid degradation studies the assay values of Ambroxol hydrochloride at the end of the 90mins and 3rd day study for standard and sample were 58.42% and 50.53% respectively. For alkali degradation studies the assay values of Ambroxol hydrochloride at the end of the 90mins and 3rd day study for standard and sample were were 70.85% and 77.06% respectively. For oxidative degradation studies the assay values of Ambroxol hydrochloride at the end of the 90mins and 3rd day study for standard and sample were were 58.42% and 43.42% respectively. Ambroxol hydrochloride was found to degrade extensively under acid, alkali and oxidative conditions. Ambroxol hydrochloride has to be stored under such condition where the possibility of acid, alkali and oxidative hydrolysis does not arise.

  • Application of quality by design (CCD technique) for simultaneous estimation of cefixime and ofloxacin by HPTLC method


  • Study of cancer causing food product material analysis by using UV spectroscopy


  • Development and validation for simultaneous estimation of sitagliptin and metformin in pharmaceutical dosage form using RP-HPLC method


  • Method development and validation of losartan potassium by RP-HPLC


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