Chidananda Swamy Rumalla
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View article: Force degradation studies of relugolix: identification, isolation and structure characterization of stress degradation products by using liquid chromatography-mass spectrometry, auto purification mass mediated preparative-high performance liquid chromatography, high resolution mass spectrometry, nuclear magnetic resonance spectroscopy
Force degradation studies of relugolix: identification, isolation and structure characterization of stress degradation products by using liquid chromatography-mass spectrometry, auto purification mass mediated preparative-high performance liquid chromatography, high resolution mass spectrometry, nuclear magnetic resonance spectroscopy Open
To assess the stability of Relugolix under stress conditions, identify and characterize the degradation products, it was subjected to hydrolytic and oxidative stress conditions, according to the International Council for Harmonization guid…
View article: STRUCTURE CHARACTERIZATION OF STRESS DEGRADATION PRODUCTS OF ELAGOLIX BY USING HRMS, NMR
STRUCTURE CHARACTERIZATION OF STRESS DEGRADATION PRODUCTS OF ELAGOLIX BY USING HRMS, NMR Open
Elagolix Sodium is a recently approved drug used to treat endometriosis in women. Elagolix sodium was exposed to forced degradation (acid, base, neutral, oxidative, thermal, and photolytic) as per International Council for Harmonisation gu…
View article: Degradation Studies of Tadalafil: Identification, Isolation and Structure Characterization ofStress Degradation Product using LC-MS, Mass Mediated Prep-HPLC, NMR, HRMS
Degradation Studies of Tadalafil: Identification, Isolation and Structure Characterization ofStress Degradation Product using LC-MS, Mass Mediated Prep-HPLC, NMR, HRMS Open
The degradation behaviour of tadalafil performed under different stress conditions according to International Conference on Harmonization guidelines (ICH) was studied. A novel degradation product (DP) of tadalafil was observed only in acid…
View article: Degradation Studies of Lacidipine: Identification, Isolation and Structural Characterizationof Stress Degradation Products using LCMS, Mass mediated Prep-HPLC, NMR and HRMS
Degradation Studies of Lacidipine: Identification, Isolation and Structural Characterizationof Stress Degradation Products using LCMS, Mass mediated Prep-HPLC, NMR and HRMS Open
The stability of lacidipine drug under stress conditions and the identification of the degradation products, according to ICH guidelines Q1A (R2) were investigated in the hydrolytic and oxidative stress conditions. The drug degradation occ…
View article: Isolation, Identification and Characterization of Gefitinib Novel Degradation Products byNMR and HRMS, Method Development and Validation by UPLC
Isolation, Identification and Characterization of Gefitinib Novel Degradation Products byNMR and HRMS, Method Development and Validation by UPLC Open
Gefitinib (GFT) sold under the brand name Iressa, is a medication used to treat certain type of breast, lung and other cancers, Gefitinib was subject to stress degradation under acidic, basic, peroxide mediated oxidation, photolytic and th…
View article: Stability Indicating LC-MS Method Development and Validation for the Study of the Forced Degradation Behavior of Pimobendan Drug
Stability Indicating LC-MS Method Development and Validation for the Study of the Forced Degradation Behavior of Pimobendan Drug Open
Objectives: Analytical methods are necessary for the field of pharmaceuticals to discover the drug, determination of drugs and metabolites in biological matrices. The present study aimed to develop liquid chromatography-tandem mass spectro…
View article: FORCED DEGRADATION STUDIES OF NILOTINIB HYDROCHLORIDE: ISOLATION, IDENTIFICATION & CHARACTERIZATION OF IMPURITIES
FORCED DEGRADATION STUDIES OF NILOTINIB HYDROCHLORIDE: ISOLATION, IDENTIFICATION & CHARACTERIZATION OF IMPURITIES Open
Nilotinib hydrochloride is a tyrosine kinase inhibitor approved for the treatment of chronic myelogenous leukemia was subjected to forced degradation studies and the samples were analyzed by utilizing the LCMS compatible HPLC methods. Nilo…
View article: DEGRADATION STUDYOF PIMAVANSERIN: IDENTIFICATION, ISOLATION AND STRUCTURAL CHARACTERIZATION OF DEGRADANTS
DEGRADATION STUDYOF PIMAVANSERIN: IDENTIFICATION, ISOLATION AND STRUCTURAL CHARACTERIZATION OF DEGRADANTS Open
Pimavanserin (PMV) is a novel antipsychotic drug that is used for the treatment of Parkinson's disease and psychosis.PMV stability is characterized by subjecting it to systematic forced degradation in various stress conditions such as acid…
View article: Hydrolytic Degradation Study of Rivaroxaban: Degradant Products Identification byLC-MS Isolation by Prep-HPLC and Characterization by HRMS, NMR and FT-IR
Hydrolytic Degradation Study of Rivaroxaban: Degradant Products Identification byLC-MS Isolation by Prep-HPLC and Characterization by HRMS, NMR and FT-IR Open
Present work illustrates the stress degradation behaviour of rivaroxaban under hydrolytic, oxidative, thermal and photolytic conditions as per ICH guidelines. Under thermal and photolytic conditions drug had a fair stability where as in ot…
View article: Isolation and Characterization of Novel Degradation Products of Valsartan by NMR and High Resolution Mass Spectroscopy: Development and Validation of Valsartan by UPLC
Isolation and Characterization of Novel Degradation Products of Valsartan by NMR and High Resolution Mass Spectroscopy: Development and Validation of Valsartan by UPLC Open
Valsartan is used to treat high blood pressure, heart failure and diabetic kidney disease. It was subjected to forced degradation under acidic, basic and peroxide mediated oxidation. The forced degradation was performed according to ICH gu…
View article: Degradation studies of levosimendan isolation, identification, and structure confirmation of stress degradation products using LCMS, mass mediated Prep-HPLC, NMR, HRMS, SFC and FTIR
Degradation studies of levosimendan isolation, identification, and structure confirmation of stress degradation products using LCMS, mass mediated Prep-HPLC, NMR, HRMS, SFC and FTIR Open
The present work describes the stress degradation behavior of Levosimendan as per ICH guidelines. Under thermal and photolytic conditions drug had a fair stability and in other stress conditions degradation products (DP) were observed. Ini…
View article: Separation of Unprecedented Degradants of Domperidone by Ultra-Performance Convergence Chromatography and Their Structure Elucidation
Separation of Unprecedented Degradants of Domperidone by Ultra-Performance Convergence Chromatography and Their Structure Elucidation Open
Domperidone, a gastroprokinetic agent, is a common drug to treat emesis. It was subjected to acid, base-mediated hydrolysis, peroxide-mediated oxidation, photolysis and thermal degradation according to ICH guidelines to observe stability o…
View article: Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR
Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR Open
The stability of aceclofenac under stress conditions was assessed to identify the degradation products. So, it was subjected to stress conditions like acid, base and oxidation, according to ICH guideline Q1A (R2). One degradation product f…
View article: STRUCTURE ELUCIDATION OF DEGRADATION PRODUCTS OF Z- ISOMER OF LULICONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT
STRUCTURE ELUCIDATION OF DEGRADATION PRODUCTS OF Z- ISOMER OF LULICONAZOLE ACTIVE PHARMACEUTICAL INGREDIENT Open
Luliconazole geometrical isomer-Z impurity, which is formed during the synthesis of Luliconazole active pharmaceutical ingredient.And isomer-Z has specific control limit is around NMT 0.50% in line with ICH guidelines.We pursued this resea…
View article: ISOLATION AND CHARACTERIZATION OF TWO NOVEL DEGRADANT PRODUCTS IN ITRACONAZOLE BY USING PREP‑HPLC, HRMS AND NMR
ISOLATION AND CHARACTERIZATION OF TWO NOVEL DEGRADANT PRODUCTS IN ITRACONAZOLE BY USING PREP‑HPLC, HRMS AND NMR Open
To in-line with the ICH guideline Q1A(R2), Itraconazole was subjected to acidic ,basic and oxidative stress .Drug was stable in all the conditions except oxidation stress.Separated the two oxidative degradation products, by using gradient …
View article: Method Development and Validation of RP-UPLC method for the determination of Dabigatran Etexilate Mesylate in API
Method Development and Validation of RP-UPLC method for the determination of Dabigatran Etexilate Mesylate in API Open
The UPLC method was developed and validated for the determination of Dabigatran Etexilate Mesylate (DEM). The chromatography was carried out on Acquity UPLC BEH C18 (100 × 2.1 mm, 1.7μm) using a mobile phase 0.1% formic acid. The analyses …