Cadila Pharmaceutical Ltd

Dholka, India

Cadila Pharmaceutical Ltd

Dholka, India
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— The Global Loratadine market size will be XX million (USD) in 2022, from the XX million (USD) in 2016, with a CAGR (Compound Annual Growth Rate) XX% from 2016 to 2022. This report studies Loratadine in Global market, especially in North America, Europe, Asia-Pacific, South America, Middle East and Africa, focuses on the top 5 Loratadine Players in each region, with sales, price, revenue and market share for top 5 manufacturer, covering Merck Bayer Group Perrigo Sun Pharma Apotex Pfizer Sandoz Mylan SL PHARM Cadila Pharmaceutical Avail 10% Discount on Single User License. Valid for the period from 15th May 2017 to 15th June 2017 Get a Free PDF Sample of Market Report at: http://www.orbisresearch.com/contacts/request-sample/299295 Market Segment by Regions, this report splits Global into several key Regions, with sales, revenue, market share of top 5 players in these regions, from 2012 to 2017 (forecast), like North America (United States, Canada and Mexico) Asia-Pacific (China, Japan, Southeast Asia, India and Korea) Europe (Germany, UK, France, Italy and Russia etc. South America (Brazil, Chile, Peru and Argentina) Middle East and Africa (Egypt, South Africa, Saudi Arabia) Split by Product Types, with sales, revenue, price, market share of each type, can be divided into Loratadine Tablet Loratadine capsules Loratadine syrup Split by applications, this report focuses on sales, market share and growth rate of Loratadine in each application, can be divided into Adult Drug Pediatric Drug Avail 15% Discount on Corporate Users License Valid for the period from 15th May 2017 to 15th June 2017 Buy the Report@ http://www.orbisresearch.com/contact/purchase/299295 About Us: Orbis Research (orbisresearch.com) is a single point aid for all your market research requirements. We have vast database of reports from the leading publishers and authors across the globe. We specialize in delivering customised reports as per the requirements of our clients. We have complete information about our publishers and hence are sure about the accuracy of the industries and verticals of their specialisation. This helps our clients to map their needs and we produce the perfect required market research study for our clients. For more information, please visit http://www.orbisresearch.com/reports/index/2017-top-5-loratadine-manufacturers-in-north-america-europe-asia-pacific-south-america-middle-east-and-africa


Trivedi H.K.,Cadila Pharmaceutical Ltd | Patel M.C.,P.A. College
Scientia Pharmaceutica | Year: 2012

A stability-indicating reversed phase ultra performance liquid chromatographic (RP-UPLC) method was developed for the determination of related substances in rosuvastatin calcium (ROSV) tablet dosage form. The chromatographic separation was achieved on an Acquity BEH C18 (100 mm × 2.1 mm, 1.7 μm) column with mobile phase containing a gradient mixture of solvent-A (0.1% trifluoroacetic acid) and solvent-B (methanol). The eluted compounds were monitored at 240 nm and the run time was 10.0 min. Degradation behavior of the ROSV was studied under various degradation stress conditions. Four major unknown degradation products (late eluting impurities) were found in acid stress condition and two unknown degradation products were found in oxidative stress condition. The developed method separates (six) unknown impurities, (three) known impurities and ROSV substance from each other, providing the stability-indicating power of the method. The developed RP-UPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. The developed and validated RP-UPLC method is LC-MS compatible and can be applied for identification of eluted unknown impurities of ROSV. © Trivedi and Patel; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria.


Trivedi H.K.,Cadila Pharmaceutical Ltd | Trivedi H.K.,P.A. College | Patel M.C.,P.A. College
Scientia Pharmaceutica | Year: 2012

A simple, sensitive, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) method, coupled with a photodiode array detector, was developed for the determination of rupatadine (RUPA) and its related substances in pharmaceutical dosage forms. Chromatographic separation was achieved on the Hypersil BDS (150 × 4.6 mm, 5 μm) column with a mobile phase containing a gradient mixture of a buffer (acetate buffer pH-6.0) and solvent (methanol). The eluted compounds were monitored at 264 nm for the related substances and assay, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 50°C. The developed method separated RUPA from its four known and three unknown impurities within 15.0 min. Rupatadine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Rupatadine was found to degrade significantly under oxidative stress conditions, and degrade slightly under acid, base, hydrolytic, thermal, and photolytic stress conditions. All impurities were well-resolved from each other and from the main peak, showing the stability-indicating power of the method. The developed method was validated as per the International Conference on Harmonization (ICH) guidelines. The developed and validated RP-HPLC method is LC-MS compatible and can be explored for the identification of eluted unknown impurities of RUPA. © Trivedi and Patel.


Kumar A.M.,Cadila Pharmaceutical Ltd.
Indian Journal of Pharmaceutical Education and Research | Year: 2010

A selective, rapid and sensitive reverse phase ultra-performance liquid chromatography method was developed for the quantitative determination of fexofenadine in human plasma. With carbamazepine as internal standard, sample pretreatment involved a one-step extraction with ethyl acetate from 980μl plasma. The sample was analyzed using 10mM KH2PO4 buffer pH 2.5 and acetonitrile (70:30 v/v) as mobile phase. Chromatographic separation was achieved on an ACQUITY UPLCTM BEH (C-18) column (1.7 μm, 2.1mm × 100mm) using isocratic elution (at a flow rate of 0.25 ml/min). The peak was detected using UV-PDA detector set at 210 nm and the total time for a chromatographic separation was 10 min. Linear calibration curves were obtained in the concentration range of 30.09-1805.39 ng/ml with a lower limit of quantification of 30.09 ng/ml. The inter- and intra- day precision (RSD) values were below 15% and accuracy (RE) was from 1.55 to 5.51% at all QC levels. The mean recoveries for fexofenadine at high, middle and low quality control samples was obtained 74.3%, 73.2% and 64.8% respectively and for internal standard was 82.8%. Developed method was found to be accurate, precise, selective and rapid for estimation of fexofenadine in plasma and can be used for pharmacokinetic and bioequivalence studies. © APTI All rights reserved.


Trivedi H.K.,Cadila Pharmaceutical Ltd | Trivedi H.K.,P.A. College | Kshtri N.,Cadila Pharmaceutical Ltd | Patel M.C.,P.A. College
Scientia Pharmaceutica | Year: 2013

The present work reports a rapid reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of 12 beta-lactam components for cleaning validation and cross-contamination. A strategic experimental approach was implemented for the method development. The desired chromatographic separation was achieved on a Symmetry C18 (4.6 X 75 mm, 3.5 μm) column using gradient elution. The optimized mobile phase consisted of the buffer tetrabutylammonium hydroxide pH-6.8 and acetonitrile. The eluted compounds were monitored at 215 nm and 254 nm wavelength using a photodiode array detector. The developed method separated 12-beta-lactam compounds from each other within a run time of 50 min. The method is effective for the determination of cross-contamination of penicillin and cephalo-sporin production blocks. The present method is specific and a lower limit of quantification was determined on the basis of the signal-to-noise ratio method; it is 1 μg/mL for all components. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. © Trivedi et al.


Trivedi H.K.,Cadila Pharmaceutical Ltd | Trivedi H.K.,P.A. College | Patel M.C.,P.A. College
Scientia Pharmaceutica | Year: 2011

A stability-indicating reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed for the determination of sodium bisulfate (SB), an antioxidant, in injectable dosage form. The chromatographic separation was achieved on a Zorbax CN (250 mm × 4.6 mm, 5 μm) column, with a mobile phase consisting of a buffer mixture of 0.03 M tetrabutylammonium hydrogen sulfate, 0.01 M potassium dihydrogen orthophosphate, and acetonitrile at a ratio of 70:30 (v/v) and a flow rate of 0.7 mL/min. The eluted compound was monitored at a wavelength of 215 nm using a UV detector. The method described herein separated sodium bisulfite from all other formulation components within a run time of 10 min. The method also generated linear results over an SB concentration range of 10 to 990 μg/mL, and the limit of quantification was found to be 10 μg/mL. The stability indicating capability of the method was established by performing forced degradation experiments. The RP-HPLC method that was developed was validated according to the International Conference on Harmonization (ICH) guidelines. This method was successfully applied in the quantitative determination of SB in a stability study of Amikacin sulfate injection. The procedure described herein is simple, selective, and reliable for routine quality control analysis as well as stability testing. © Trivedi and Patel.


Mehta J.,Cadila Pharmaceutical Ltd. | Patidar K.,Cadila Pharmaceutical Ltd. | Vyas N.,Cadila Pharmaceutical Ltd.
E-Journal of Chemistry | Year: 2010

A simple and precise reversed phase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC) preservative in pharmaceutical formulation of latanoprost eye drops. The analyte was chromatographed on a Waters Spherisorb CN, (4.6x250 mm) column packed with particles of 5 μm. The mobile phase, optimized through an experimental design, was a 40:60 (v/v) mixture of potassium dihydrogen orthophosphate buffer (pH 5.5) and acetonitrile, pumped at a flow rate of 1.0 mL/min at maintaining column temperature at 30 oC. Maximum UV detection was achieved at 210 nm. The method was validated in terms of linearity, repeatability, intermediate precision and method accuracy. The method was shown to be robust, resisting to small deliberate changes in pH, flow rate and composition (organic ratio) of the mobile phase. The method was successfully applied for the determination of BKC in a pharmaceutical formulation of latanoprost ophthalmic solution without any interference from common excipients and drug substance. All the validation parameters were within the acceptance range, concordant to ICH guidelines.


A simple, precise, shorter runtime and stability indicating reversephase high performance liquid chromatographic method has been developed and validated for the quantification of benzalkonium chloride (BKC) preservative in pharmaceutical formulation of sparfloxacin eye drop. The method was successfully applied for determination of benzalkonium chloride in various ophthalmic formulations like latanoprost, timolol, dexametasone, gatifloxacin, norfloxacin, combination of moxifloxacin and dexamethasone, combination of nepthazoline HCl, zinc sulphate and chlorpheniramine maleate, combination of tobaramycin and dexamethasone, combination of phenylephrine HCl, naphazoline HCl, menthol and camphor. The RP-LC separation was achieved on an Purospher Star RP-18e 75 mm × 4.0 mm, 3.0 μ in the isocratic mode using buffer: acetonitrile (35: 65, v/v), as the mobile phase at a flow rate of 1.8 mL/min. The methods were performed at 215 nm; in LC method, quantification was achieved with PDA detection over the concentration range of 50 to 150 μg/mL. The method is effective to separate four homologs with good resolution in presence of excipients, sparfloxacin and degradable compound due to sparfloxacin and BKC within five minutes. The method was validated and the results were compared statistically. They were found to be simple, accurate, precise and specific. The proposed method was validated in terms of specificity, precision, recovery, solution stability, linearity and range. All the validation parameters were within the acceptance range and concordant to ICH guidelines.


Trivedi H.K.,Cadila Pharmaceutical Ltd | Patel M.C.,P.A. College
International Journal of ChemTech Research | Year: 2010

A simple reversed-phase high performance liquid chromatography has been developed and employed for the analysis of Omeprazole and its related substances in bulk material and commercial dosage forms. A gradient elution of filtered sample was performed on Zorbax XDB C8 (150 x 4.6), 5μ column with Glacine buffer (pH -8.8) as a mobile phase-A, Acetonitrile: Methanol (83:17) as a mobile phase-B and UV detection at 302 nm. Mobile phase was delivered at flow of 1.2 mL/min and at maintaining the column temperature at 25oC, quantification was achieved with reference to the external standards. The active ingredient-omeprazole was successfully separated from its all related substances, including process impurities and other possible impurities of oxidation and decomposition. The excipients did not interfere with the determination of omeprazole and its related compound in commercial dosage formulations. The method was rapid, simple, accurate and reproducible. It was not only successfully employed for the assay of omeprazole in bulk material and pharmaceutical dosage forms but also for the determination of its related substances. A statistical design of experiments was used for the robustness evaluation of HPLC analysis method. All results were acceptable and confirmed that the method is suitable for its intended use.


Mehta J.,Cadila Pharmaceutical LTD. | Patel V.,Cadila Pharmaceutical LTD. | Kshatri N.,Cadila Pharmaceutical LTD. | Vyas N.,Cadila Pharmaceutical LTD.
Analytical Methods | Year: 2010

A challenging and multipurpose stability-indicating HPLC method is developed and validated for the quantification of latanoprost, timolol, benzalkonium chloride (BKC) and related substances in the presence of their degradation products in ophthalmic solution. Various stress conditions, e.g. acid, base, oxidation, heat, UV radiation and heat were employed to assess the stability-indicating nature of the method. A strategic experimental approach was implemented for the method development. The desired chromatographic separation was achieved on a reverse phase cyano column {Hypersil BDS CN (250 × 4.6 mm), 5 μm} under gradient elution conditions. A mixture of phosphate buffer of pH 3.2, acetonitrile and methanol was used as the mobile phase. The determination was carried out at 295 nm and 210 nm. Due to the very low content of latanoprost (0.005%) in the formulation, the injection volume was optimized as 80 μl in order to achieve an optimum response. In totality, peaks of latanoprost and its two known impurities, four BKC homologs, timolol and its known impurities were obtained with a minimum resolution of 3.0. This sensitive method was found to be precise and linear through out the range with a lowest quantification of 0.068 μg ml -1 for 15-keto latanoprost, 0.030 μg ml -1 for latanoprost acid, 0.018 μg ml -1 for latanoprost (unknown impurity), 0.011 μg ml -1 for timolol impurity I and 0.013 μg ml -1 for timolol (unknown impurity). The method was validated according to ICH guidelines. This versatile method can be used as a combined assay and related substance method for said ophthalmic solution formulation. © 2010 The Royal Society of Chemistry.

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