MSN Laboratories Pvt Ltd

Medak, India

MSN Laboratories Pvt Ltd

Medak, India

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Sreenivasulu J.,Sri Krishnadevaraya University | Sreenivasulu J.,MSN Laboratories Pvt Ltd | Venkata Ramana P.,Sri Krishnadevaraya University | Sampath Kumar Reddy G.,MSN Laboratories Pvt Ltd | And 3 more authors.
Journal of Chromatographic Science | Year: 2015

A novel, rapid, specific and stability-indicating reverse-phase high-performance liquid chromatography method was developed for the quantitative determination of related compounds, obtained from two different synthetic routes and degradation products of Azilsartan kamedoxomil (AZL). The method was developed by using a YMC-Pack pro C18 (150 × 4.6 mm, 3 μm) column with a mobile phase containing a gradient mobile phase combination. The eluted compounds were measured at wavelength 220 nm. The developed method run time was 25 min, within which AZL and its eight impurities were well separated with minimum 3.0 resolution. The drug substance was subjected to stress conditions of hydrolysis (acid, base and water), oxidation, photolysis, sunlight, 75% relative humidity and thermal degradation as per International Conference on Harmonization (ICH) prescribed stress conditions to ascertain the stability-indicating power of the method. Significant degradation was observed during acid, base, peroxide, water hydrolysis and 75% relative humidity studies. The mass balance of AZL was close to 100% in all the stress condition. The developed method was validated as per the ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. © The Author 2015. Published by Oxford University Press.


Sreenivasulu J.,Sri Krishnadevaraya University | Sreenivasulu J.,MSN Laboratories Pvt. Ltd. | Venkata Ramana P.,Sri Krishnadevaraya University | Sampath Kumar Reddy G.,MSN Laboratories Pvt. Ltd. | And 6 more authors.
Journal of Chromatographic Science | Year: 2016

A novel, simple, sensitive and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of the geometric isomer (Trans) and other related substances in the active pharmaceutical ingredient (API) of Tafluprost (TFL), with their determination by an assay. A chromatographic separation of TFL and its impurities was achieved with a C18 analytical column, using gradient elution with mobile phase A consisting of a mixture of water, methanol and orthophosphoric acid (900:100:1, v/v) and mobile phase B consisting of a mixture of acetonitrile and water (900:100, v/v). The instrumental settings included a flow rate of 1.0 mL/min for related substances and 1.2 mL/min for the assay, a column temperature of 50°C and a detector wavelength of 210 nm, using a photodiode array detector. TFL was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions and the stressed samples were analyzed by the proposed method. Peak homogeneity data of TFL were obtained by using a photodiode array detector in the stressed sample chromatograms, which demonstrated the specificity of the method for estimation in the presence of degradants. The developed method was validated for parameters such as precision, accuracy, linearity, limit of detection, limit of quantification, ruggedness and robustness as per ICH guidelines. © 2016 The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.


PubMed | MSN Laboratories Pvt Ltd and Sri Krishnadevaraya University
Type: Journal Article | Journal: Journal of chromatographic science | Year: 2015

A novel, rapid, specific and stability-indicating reverse-phase high-performance liquid chromatography method was developed for the quantitative determination of related compounds, obtained from two different synthetic routes and degradation products of Azilsartan kamedoxomil (AZL). The method was developed by using a YMC-Pack pro C18 (150 4.6 mm, 3 m) column with a mobile phase containing a gradient mobile phase combination. The eluted compounds were measured at wavelength 220 nm. The developed method run time was 25 min, within which AZL and its eight impurities were well separated with minimum 3.0 resolution. The drug substance was subjected to stress conditions of hydrolysis (acid, base and water), oxidation, photolysis, sunlight, 75% relative humidity and thermal degradation as per International Conference on Harmonization (ICH) prescribed stress conditions to ascertain the stability-indicating power of the method. Significant degradation was observed during acid, base, peroxide, water hydrolysis and 75% relative humidity studies. The mass balance of AZL was close to 100% in all the stress condition. The developed method was validated as per the ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.


Sahadev Reddy M.,MSN Laboratories Pvt. Ltd | Sahadev Reddy M.,Rayalaseema University | Reddy M.S.N.,MSN Laboratories Pvt. Ltd | Rajan S.T.,MSN Laboratories Pvt. Ltd | And 2 more authors.
Der Pharma Chemica | Year: 2016

An improved and efficient synthetic process developed for an oxidation of primary alcohols to related aldehydes with commercially cheaper trichloroisocyanuric acid in presence of catalyst TEMPO (2, 2, 6, 6-tetra methyl-1-piperidinyloxy Free radical). This synthetic approach efficiently provides highly pure aldehydes without formation of the acid impurity. In the present process overall yields are around 90-95%.


Sahadev Reddy M.,MSN Laboratories Pvt. Ltd | Sahadev Reddy M.,Rayalaseema University | Reddy M.S.N.,MSN Laboratories Pvt. Ltd | Rajan S.T.,MSN Laboratories Pvt. Ltd | And 2 more authors.
Der Pharma Chemica | Year: 2016

In the synthesis of Esmolol hydrochloride four prominent process impurities were formed during synthesis. These impurities were detected in gradient HPLC method. These impurities are synthesized in different synthesis methods and characterized as 3-(4-(2-hydroxy-3-(isopropyl amino) propoxy) phenyl)propanoic acid (Esmolol free acid), Methyl 3-4-[3-(ethyl amino)-2-hydroxy propoxy]phenyl propionate (Esmolol isopropyl amide analog), 3-(4-(2-hydroxy-3(isopropylamino)propoxy)phenyl)-N-isopropylpropanamide (N-Ethyl Esmolol), Methyl 3-(4-(2-hydroxy-3-(3-(4-(2-hydroxy-3-(isopropylamino) propoxy) phenyl)-N-isopropyl propanamido) propoxy)phenyl)propanoate (Esmolol dimer) by 1H NMR, IR and Mass spectral data. Synthesis and Structural elucidation by spectral data is discussed.


Sahadeva Reddy M.,MSN Laboratories Pvt. Ltd | Sahadeva Reddy M.,Rayalaseema University | Reddy M.S.N.,MSN Laboratories Pvt. Ltd | Rajan S.T.,MSN Laboratories Pvt. Ltd | And 2 more authors.
Der Pharma Chemica | Year: 2016

A novel and efficient synthetic process developed for Pitavastatin calcium by preparation of key intermediate 2 with high yield and quality by condensing 2-cyclopropyl-4-(4-fluorophenyl)-3-((1-methyl-1H-benzo[d]imidazol-2- ylsulfonyl)methyl) quinoline 13 with (3R,5S)-tert-butyl 3,5-dimethoxy-6-oxohexanoate 10. This synthetic approach efficiently provides highly pure Pitavastatin calcium with high yields.


Kotla N.R.,MSN Laboratories Pvt. Ltd | Kotla N.R.,Rayalaseema University | Nagaraju Ch V.S.,MSN Laboratories Pvt. Ltd | Rajan S.T.,MSN Laboratories Pvt. Ltd | And 4 more authors.
Der Pharma Chemica | Year: 2013

A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of the related impurities of Fesoterodine Fumarate drug substance. The method was optimized using buffer (prepared by dissolving 3mL H3PO4 (85%) and 1.0gm 1-Octane sulphonoic acid sodium salt anhydrous taken in 1000mL milli-Q-water and then pH was adjusted to ~ 7.2 with dilute potassium hydroxide solution) taken along with Acetonitrile 60:40v/v as mobilephase-A, and Acetonitrile: water in the ratio of 90:10 v/v as mobile phase-B. The flow rate was set at 1.2 mL min-1, wavelength at 220nm respectively and the column temperature was maintained at 45°C. The capability of stability indicating method developed was demonstrated by studying the degradation products generated during the forced degradation studies under the following conditions i) water hydrolysis, ii) at 75% relative humidity, iii) oxidative, iv) thermal v) photolytic, vi) acid, vii) base, and viii) photolytic degradation. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.


Kotla N.R.,MSN Laboratories Pvt. Ltd | Kotla N.R.,Rayalaseema University | Nagaraju C.V.S.,MSN Laboratories Pvt. Ltd | Rajan S.T.,MSN Laboratories Pvt. Ltd | And 6 more authors.
Der Pharma Chemica | Year: 2014

A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of the related impurities of Fingolimod hydrochloride drug substance. The method was optimized using buffer (prepared by dissolving 2.72gr KH2PO4 and 2.0gm 1-Octane sulphonoic acid sodium salt anhydrous taken in 1000mL milli-Qwater and then pH was adjusted to ~ 3.0 with dilute orthophospharic acid solution) as mobilephase-A, and Acetonitrile: water in the ratio of 90:10 v/v as mobile phase-B. The flow rate was set at 1.2 mL min-1, wavelength at 220nm respectively and the column temperature was maintained at 45 °C. The capability of stability indicating method developed was demonstrated by studying the degradation products generated during the forced degradation studies under the following conditions i) water hydrolysis, ii) at 75% relative humidity, iii) oxidative, iv) thermal v) photolytic, vi) acid, vii) base, and viii) photolytic degradation. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.


Govindu S.K.R.,MSN Laboratories Pvt. Ltd | Govindu S.K.R.,Rayalaseema University | Nagaraju C.V.S.,MSN Laboratories Pvt. Ltd | Rajan S.T.,MSN Laboratories Pvt. Ltd | And 3 more authors.
Der Pharma Chemica | Year: 2014

A reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of the related impurities of Aliskiren Hemifumarate drug substance. The method was optimized using buffer (prepared by dissolving 2.72gr potassium di hydrogen phosphate and 7.0g 1-Octane sulphonoic acid sodium salt anhydrous taken in 1000mL milli-Q-water and then pH was adjusted to 2.7with dilute orthophospharic acid solution) taken along with Acetonitrile 70:30v/v as mobilephase-A, and Acetonitrile: water in the ratio of 90:10 v/v as mobile phase-B. The flow rate was set at 1.0mL min-1, wavelength at 230nm respectively and the column temperature was maintained at 45°C. The capability of stability indicating method developed was demonstrated by studying the degradation products generated during the forced degradation studies under the following conditions i) water hydrolysis, ii) at 75% relative humidity, iii) oxidative, iv) thermal v) photolytic, vi) acid, vii) base, and viii) photolytic degradation. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.


Kotla N.R.,MSN Laboratories Pvt. Ltd | Kotla N.R.,Rayalaseema University | Nagaraju C.V.S.,MSN Laboratories Pvt. Ltd | Rajan S.T.,MSN Laboratories Pvt. Ltd | And 5 more authors.
Der Pharma Chemica | Year: 2014

reverse phase liquid chromatographic (RP-LC) method was developed for the quantification of the related impurities of Bepotastine besilate drug substance. The method was optimized using buffer (prepared by dissolving 1.0mL H3PO4 (85%) taken in 1000mL milli-Q-water and then pH was adjusted to 3.0 with dilute triethylamine solution) as mobilephase-A, and Acetonitrile : Methanol : water in the ratio of 70:20:10 v/v/v as mobile phase-B. The flow rate was set at 1.0 mL min-1, wavelength at 225nm respectively and the column temperature was maintained at 45 ° C. The capability of stability indicating method developed was demonstrated by studying the degradation products generated during the forced degradation studies under the following conditions i) water hydrolysis, ii) at 75% relative humidity, iii) oxidative, iv) thermal v) photolytic, vi) acid, vii) base, and viii) photolytic degradation. The developed method can be used for the determination of synthetic and degradation impurities in the regular quality control analysis for the drug substance.

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