A Randomized, Double Blind, Placebo Controlled, Three arm, Parallel, Multicentre, Study to Evaluate the Bioequivalence using Clinical Endpoint of Pimecrolimus Cream, 1% of Encube Ethicals Private Limited, India to Pimecrolimus Cream, 1% of Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Treatment of Mild to Moderate Atopic Dermatitis. - Nil

开始日期2024-03-15

申办/合作机构

Encube Ethicals Pvt Ltd.

CTRI/2024/01/061161 / RecruitingN/A

A Multicenter, Randomized, Double-Blind, Three-Arm, Placebo-Controlled, Parallel Design, Study to Evaluate the Efficacy and Safety of Ketoconazole 2% Shampoo of Encube Ethicals Private Limited, India with Ketoconazole Shampoo, 2% of Padagis (Perrigo) Allegan, MI 49010 in Subjects with Tinea Versicolor. - NIL

开始日期2024-01-15

申办/合作机构

Encube Ethicals Pvt Ltd.

[+1]

CTRI/2023/01/049053 / Recruiting临床1期

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Tretinoin Gel Microsphere, 0.06% (Encube Ethicals Private Limited, India) to Retin-A MicroÂ® (Tretinoin) Gel Microsphere, 0.06% (Valeant Pharmaceuticals North America LLC, NJ 08807, USA) in Subjects with Acne Vulgaris. - G7SYN/P-001/2022

开始日期2023-03-01

申办/合作机构

Encube Ethicals Pvt Ltd.

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2024-04-23·Journal of Chromatographic Science

RP-LC Method Development and Validation for Dasatinib Forced Degradation Study: Isolation and Structural Characterization by NMR and HRMS

Article

作者: Senadi, Gopal C ; Mahapatra, Sudarshan ; Kavitapu, Dasameswara Rao ; Murty, Jayanti Naga Sri Rama Chandra ; Maruthapillai, Arthanareeswari

AbstractA reverse phase high-performance liquid chromatography (HPLC) method has been developed for the quantification of a typical drug Dasatinib (DST) and its related impurities in pharmaceuticals. Kinetex C18 (4.6 × 150 mm, 5 μm) column was used in the chromatographic separations, using buffer (1.36 g of KH2PO4 in 1000 mL of water, pH = 7.8; adjusted with diluted KOH solution) with solvent as acetonitrile and mode of elution as the gradient. The flow rate is 0.9 mL/min, column oven temperature as 45°C and the overall gradient run time as 65 min. The developed method was found to produce symmetric and good separation between the process-related and degradation impurities. Method optimization is achieved with photodiode array at 305 nm over the concentration range of 0.5 mg/mL and degradation studies were carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability indicating capability of the method. Two major impurities were found in forced degradation studies in the HPLC analysis, the unknown, acid degradants were enriched and isolated by preparative HPLC, then characterized through high-resolution mass spectrometry, nuclear magnetic resonance spectroscopy and Fourier transform infrared spectroscopy. The unknown acid degradation impurity was showing Exact Mass of 521.11, molecular formula C22H25Cl2N7O2S and its chemical name as 2-(5-chloro-6-(4-(2-hydroxyethyl) piperazin-1-yl)-2-methylpyrimidin-4-ylamino)-N-(2-chloro-6-methylphenyl) thiazole-5-carboxamide. Another impurity (oxidative degradant) found as known DST N-oxide Impurity-L and its chemical name as 4-(6-((5-((2-chloro-6-methylphenyl) carbamoyl) thiazol-2-yl) amino)-2-methylpyrimidin-4-yl)-1-(2-hydroxyethyl) piperazine 1-oxide. The analytical HPLC method was further validated as per ICH guidelines.

2024-02-02·Journal of Chromatographic Science

A Multi-Analyte LC–MS/MS Method for Determination and Quantification of Six Nitrosamine Impurities in Sartans like Azilsartan, Valsartan, Telmisartan, Olmesartan, Losartan and Irbesartan

Article

作者: Maruthapillai, Arthanareeswari ; Mahapatra, Sudarshan ; Gopireddy, Ramana Reddy

AbstractA sensitive and robust method for determination and quantification of potential genotoxic impurities in sartans has been developed. These impurities need to be controlled at trace levels during quantification in drug substances and drug products for safe consumption. Recent regulatory requirements also suggested the need to have highly sensitive analytical method for trace level quantification of nitrosamine impurities. In this paper, we have described a simple, rapid and sensitive liquid chromatography-mass spectrometry method for six potential genotoxic nitrosamine impurities: N-Nitroso dimethyl amine (NDMA), N-Nitroso diethyl amine (NDEA), N-Nitroso Ethyl Iso propylamine (NIPEA), N-Nitroso-Nmethyl-4-aminobutyric acid (NMBA) N-Nitroso diisopropylamino (NDIPA) and N-Nitroso dibutyl amine (NDBA) in Azilsartan (AZL), Valsartan (VAL), Telmisartan (TEL), Olmesartan (OLM), Losartan (LOS) and Irbesartan (IRB) with a limit of quantification of less than 0.003 ppm. Chromatographic separation is achieved using Poroshell HPH- C18, 150 × 4.6 mm, 2.7 μm column with 0.1% formic acid in water as mobile phase A and 0.1% formic acid in methanol as mobile phase B at a flow rate of 0.5 mL/min using gradient mode of elution at a total run time of 20 min. Six nitrosamine impurities are ionized and quantified in positive mode of atmospheric pressure chemical ionization using multiple reaction monitoring. As per ICH guidelines, method validation is performed and evaluated the limit of quantification and detection and found to give good S/N ratios with good linearity range of 0.003–0.045 ppm with regression coefficient > 0.999 for all the six nitrosamine impurities. Method recoveries are also established using three-step sample preparation and are found to be satisfactory within 80–120%. The single method can be used routinely applied for the detection of nitrosamines in AZL, VAL, TEL, OLM, LOS and IRB.

2022-04-28·Journal of Chromatographic Science4区 · 化学

Development and Validation of a LC–MS/MS Method for the Profiling of Impurities Formed during Stress Study of Antifungal Agent—Efinaconazole

4区 · 化学

Article

作者: Govindarajan, S ; Asharani, I V

AbstractLiquid chromatography interfaced with mass spectroscopy (LC–MS) is a sensitive and effective analytical method that combines high-resolution separation as well as specific mass detection of impurities in formulated products and as well as in active pharmaceutical ingredient (API). In this study, LC–MS/MS was used to determine impurities formed during the stability period of Efinaconazole (EFZ, a triazole antifungal agent). The method was validated for its assay parameters such as specificity, linearity, accuracy, precision and also for solution stability. The calibration curve was found to be linear for the concentration range from 0.5 μg/mL to 30 μg/mL. A thorough investigation was performed by exposing Efinaconazole (1 mg/mL) to various stress conditions such as hydrolysis (acid and alkaline), oxidation, photolysis and temperature at various time intervals to achieve 10% degradation. The impurities formed during forced degradation were separated using high-performance liquid chromatography later it was identified using LC–MS/MS technique. The obtained results showed that EFZ is prone to oxidation when exposed to a 3% aqueous medium of hydrogen peroxide solution and quite stable in all the remaining stress conditions for a longer period.

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