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Sunil Kumar Reddy A.,Bharat Institute of Technology Pharmacy | Sunil Kumar Reddy A.,Aurobindo Pharma Ltd.
International Journal of ChemTech Research | Year: 2015

A novel approach was used to develop and validate a rapid, accurate, precise, simple, efficient and reproducible isocratic Reversed Phase-High Performance Liquid Chromatographic (RP-HPLC-DAD) method for the simultaneous estimation of Netupitant and Palonosetron in bulk and pharmaceutical dosage form with forced degradation studies. Netupitant and Palonosetron was separated using Kromasil C18 column (250mm×4.6mm, 5mm particle size), Waters Alliance e2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of 0.01M Ammonium acetate buffer (pH adjusted to 3.5 with orthophosphoric acid) and Acetonitrile (65:35, v/v). The flow rate was set to 1ml/min with the responses measured at 265nm. The retention time of Netupitant and Palonosetron was found to be 2.438min and 3.718min respectively with resolution of 8.08. Linearity was established for Netupitant and Palonosetron in the range of 75-450μg/ml for Netupitant and 0.125-0.75μg/ml for Palonosetron with correlation coefficients (r2=0.999). The percentage recoveries were between 99.85% to 100.04% and 99.73% to 100.03% for Netupitant and Palonosetron respectively. RP-HPLC method for the simultaneous estimation of Netupitant and Palonosetron in their combine dosage form was established and validated as per the ICH guidelines. Netupitant and Palonosetron are more sensitive towards acidic degradation condition and moderate degradation towards alkaline, thermal and very much resistant towards oxidative, photolytic and water degradation. The developed method was successfully applied for the quantification of Netupitant and Palonosetron in bulk and pharmaceutical dosage form. © 2015, Sphinx Knowledge House. All rights reserved.


Kumar P.B.R.,Bharat Institute of Technology Pharmacy | Subramaniyan S.,Bharat Institute of Technology Pharmacy
Rasayan Journal of Chemistry | Year: 2011

When one biologically active molecule is linked to another, the resultant molecule generally has increased potency. Hence two pharmacophores, i.e. pyrazole ring and indole moiety are fused to obtain highly potent, more specific and less toxic agent. In the present study , synthesis of tide compounds 1-[(2-methyl-1H-indol-3-yl)carbonyl] -3-substituted phenyl-1H-pyrazole-4- carbaldehyde derivatives (VI-e) by using Vilsmeir-Haack reagent (DMF/POCl 3). The facial synthesis of l-[(2-methyl-1H-indol-3-yl) carbonyl] -3-substituted phenyl-1H-pyrazole-4-carbaldehyde derivatives (VI-e) has been achieved by the reaction of phenyl hydrazine(1) with a mixture of ethyl aceto acetate (II) and glacial acetic acid to synthesize ethyl-2-indole-3-carboxylate (III) which on condensation with different acetophenones in methanol in the presence of glacial acetic acid affords hydrazones (TVa-e). The hydrazones (IVa-e) on treatment with vilsmeier-Hacck reagent furnished 1-[(2-methyl-1H- indol-3-yl) carbonyl] -3-substituted phenyl-1H-pyrazole-4-carbaldehyde derivatives (VI-e). © 2011 RASÄYAN. All rights reserved.


Reddy A.S.K.,Bharat Institute of Technology Pharmacy
Asian Journal of Chemistry | Year: 2015

A novel liquid chromatography tandem mass spectrometry method is developed for the quantitative determination of entacapone in human plasma in positive ion mode and validated using tolcapone as internal standard according to linearity, selectivity, precision, recovery and various stability studies. Sample preparation was accomplished by liquid-liquid extraction technique. The eluted samples were chromatographed on ACE 3 C18 (150 × 4.6 mm, 5 μ) column (Agilent Technologies) using a mobile phase consisting of HPLC grade acetonitrile:10 mM ammonium phosphate (50:50, v/v) with injection volume of 15 μL and a run time of 3 min. The precursor to product ion transitions m/z 305.10 to 242.10 (entacapone) and m/z 272.20 to 212.10 (tolcapone) were used for quantization. The calibration graph of entacapone was linear with r2 > 0.99 over a concentration range of 60.0 ng/mL to 2200.0 ng/mL. CV % of intra- and inter-day precisions were found satisfactory and well within the limits. The drug was found to be stable for the studied parameters and found to be interference free for matrix effect with appreciable recovery. The novelty of the method makes it highly valuable, rapid, selective and sensitive for quantification of entacapone in human plasma and can be used in therapeutic drug monitoring of this drug.


Sunil Kumar Reddy A.,Bharat Institute of Technology Pharmacy | Sunil Kumar Reddy A.,Aurobindo Pharma Ltd.
Research Journal of Pharmacy and Technology | Year: 2015

The present study describes about novel approach to develop and validate a rapid, accurate, precise, simple, efficient and reproducible isocratic Reversed Phase-High Performance Liquid Chromatographic (RP-HPLCDAD) method for the estimation of Eluxadoline in bulk and pharmaceutical dosage form. Eluxadoline were separated using Hypersil C18 column (250mm×4.6 mm, 5μm particle size), Waters Alliance e2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of Acetonitrile and Water (70:30, v/v). The flow rate was set to 1ml/min with the responses measured at 260nm. The retention time of Eluxadoline was found to be 3.481min.Linearity was established for Eluxadoline in the range of 10-125μg/ml with correlation coefficient (r2=0.999). The percentage recoveries were between 99.92% to 100.07%. Validation parameters such as specificity, linearity, precision, accuracy, robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The developed method was successfully applied for the quantification and hyphenated instrumental analysis. © RJPT All right reserved.


Kilaru A.,Bharat Institute of Technology Pharmacy
Research Journal of Pharmaceutical, Biological and Chemical Sciences | Year: 2011

The present study was designed to isolate the flavonoid Chitosan from the ethanol extract of leaves of Bridelia retusa. phytochemical screening was carried out according to standard procedures from the leaves of Bridelia retusa. The isolated flavonoid was characterized by spectral studies and screened for anti-inflammatory and analgesic activity in experimental animal models. The anti inflammatory activity was determined by formalin induced paw edema and carrageenan induced paw-edema method, and the analgesic activity was determined by tail flick method and hot plate latency method by using external standard indomethacin and Chitosan isolated from ethanol extract of Bridelia retusa. Chitosan significantly (P<0.05) showed the anti-inflammatory and analgesic activity in experimental animals. Therefore the present study justifies that the isolated flavonoid exhibits significant analgesic and anti-inflammatory activity at a dose of 250 mg/kg.


A novel approach was used to develop and validate a rapid isocratic Reversed Phase-High Performance Liquid Chromatographic method for the simultaneous estimation of Metformin Hydrochloride and Canagliflozin in bulk and pharmaceutical tablet dosage form with forced degradation studies. The separation was performed by using Kromasil C18 column (250mm?4.6 mm, 5mm particle size), Waters Alliance e2695 HPLC system with 2998 PDA detector and mobile phase contained a mixture of 0.01M Ammonium acetate (pH adjusted to 3.5 with orthophosphoric acid) and Acetonitrile (65:35, v/v). The flow rate was set to 1ml/min with responses measured at 254nm. The retention time of Metformin Hydrochloride and Canagliflozin was 2.440min and 3.713min respectively with resolution of 8.95.Linearity was established in the range of 50-300μg/ml for Metformin Hydrochloride and 5-30μg/ml for Canagliflozin with correlation coefficients (r2 =0.999). The percentage recoveries were between (99.45%-100.65%) and (99.95%-100.74%) for Metformin Hydrochloride and Canagliflozin respectively. Validation parameters were evaluated according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The forced degradation studies were performed by using HCl, NaOH, H2 O2, thermal, UV radiation and water. Metformin Hydrochloride and Canagliflozin are more sensitive towards oxidative degradation condition. The developed method was successfully applied for the quantification and hyphenated instrumental analysis.


Ashok Kumar K.,Bharat Institute of Technology Pharmacy | Ramachandra Shetty S.,King Faisal University | Narsu L.,Jawaharlal Nehru University
E-Journal of Chemistry | Year: 2011

A simple, precise and accurate high-performance thin-layer chromatographic method has been established for the determination of rutin in the stem extract of Hibiscus micranthus Linn. A flavonoid fraction of methanolic extract of the stem powder was used for the experimental work. Separation was performed on silica gel 60 F 254 HPTLC plates with n-butanol: acetic acid: water: ammonia 3:1:1:1(v/v), as mobile phase. The determination was carried out using the densitometric absorbance mode at 286 nm. Rutin response was linear over the range 50-400 ng/μL. The concentration of rutin in the flavanoidal fraction was found to be 9.93%. The HPTLC method was evaluated in terms of sensitivity, accuracy, precision and reproducibility.


Ashwini Kumar G.,Therdose Pharma Pvt. Ltd | Choudhary R.K.,Therdose Pharma Pvt. Ltd | Chaitanya C.,Bharat Institute of Technology Pharmacy
Asian Journal of Pharmaceutical and Clinical Research | Year: 2011

The purpose of present work was to enhance the solubility and dissolution rate of Irbesartan by solid dispersion technology employing various super disintegrants such as sodium starch glycolate (SSG), crosspovidone (CP), croscarmellose sodium (CCS) and microcrystalline cellulose (MCC). Solid dispersions were prepared by physical mixing and solvent evaporation method. Various ratios of drug and carriers were used in the preparation in the ratio of 1:1, 1:2 and 1:4. Phase solubility studies of pure drug and solid dispersion was performed. It was found that solubility of Irbesartan was increased. All the solid dispersions prepared were found to be fine free flowing powders and the drug content was uniform in all batches. The results of the disintegration test revealed that F5 has faster disintegration and it disintegrates within two minutes (95secs). The dissolution of Irbesartan from all the solid dispersions was rapid and several times higher than the dissolution of the corresponding pure drug and followed first order kinetics. All the dissolution parameters estimated i.e. T50, T90, DE30% values indicated rapid and higher dissolution of the drug (Irbesartan) from solid dispersions than that of corresponding pure drug. CP showed highest enhancement of dissolution rate and efficiency of Irbesartan. In each case the dissolution rate (K1) and DE30% were increased as the concentration of superdisintegrants in the solid dispersions was increased. The order of increase in dissolution rate with various superdisintegrants CP > SSG > CCS > MCC with Irbesartan. Among all in-house formulations F5 showed maximum dissolution i.e. 4.25 and 6.15 fold increase in DE30% and dissolution rate (K1) were observed with formulation F5. FT-IR studies revealed that there was no chemical interaction between drug and carrier when formed as solid dispersion.


Shalini S.,Bharat Institute of Technology Pharmacy | Ravindra Reddy Y.,Bharat Institute of Technology Pharmacy
International Journal of Pharmacy and Technology | Year: 2011

A simple, precise, accurate, and rapid HPLC method has been developed, and validated for the determination of levodopa and Carbidopa simultaneously, in combined tablet dosage form. The mobile phase used was a mixture of phosphate buffer pH 3 and Acetonitrile (90:10% v/v). The detection of levodopa and Carbidopa was carried out by UV detector at 280 nm. The retention time of levodopa and carbidopa were found to be 3.2 and 4.6 respectively. Results of the analysis were validated statistically, and by recovery studies. The proposed method can be successfully used to determine the drug contents of marketed formulation. Key words: Levodopa, Carbidopa, Reverse Phase High Performance Liquid Chromatography and validation.


Raja S.,Bharat Institute of Technology Pharmacy | Srilakshmi S.,Bharat Institute of Technology Pharmacy
Toxicological and Environmental Chemistry | Year: 2010

The aim of present study was to validate hepatoprotective and antioxidant activities of the bark of Bridelia retusa. The aqueous ethanol extract of B. retusa exhibited highest in vitro hepatoprotective effects as evident from the significantly reduced serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) into the incubation medium of rat hepatocytes with carbon tetrachloride (CCl4), over the other organic extracts (chloroform, ethylacetate, and methanol). CCl4 administered through subcutaneous injection produced a marked elevation in the serum levels of GOT, GPT, lactate dehydrogenase, alkaline phosphatase, bilirubin, thiobarbituric acid reactive substances, and decreased in the levels of reduced glutathione, superoxide dismutase, catalase, glutathione-S-transferase, glutathione reductase, glutathione peroxidase, and total protein content. The biochemical activities were normalized in the pretreatment of rats induced by CCl4 with different doses (250 and 500 mg kg-1) of the aqueous ethanol extract of B. retusa. Histopathological changes induced by CCl4 were also significantly attenuated by aqueous ethanol extract of B. retusa treatment. The activity of the aqueous ethanol extract of B. retusa at the dose of 500 mg kg-1 was comparable to the standard drug, silymarin (25 mg kg-1). The overall data indicated that B. retusa possesses a potent protective effect against CCl4-induced hepatic damage and oxidative stress. © 2010 Taylor & Francis.

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