Cb Patel Research Center

Mumbai, India

Cb Patel Research Center

Mumbai, India

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Kukshal P.,University of Delhi | Kukshal P.,Cb Patel Research Center | Bhatia T.,Dr Rml Hospital | Bhagwat A.M.,Cb Patel Research Center | And 5 more authors.
Schizophrenia Research | Year: 2013

Background: Neuregulin-1 (NRG1) gene polymorphisms have been proposed as risk factors for several common disorders. Associations with cognitive variation have also been tested. With regard to schizophrenia (SZ) risk, studies of Caucasian ancestry samples indicate associations more consistently than East Asian samples, suggesting heterogeneity. To exploit the differences in linkage disequilibrium (LD) structure across ethnic groups, we conducted a SZ case-control study (that included cognitive evaluations) in a sample from the north Indian population. Methods: NRG1 variants (n = 35 SNPs, three microsatellite markers) were initially analyzed among cases (DSM IV criteria, n = 1007) and controls (n = 1019, drawn from two groups) who were drawn from the same geographical region in North India. Nominally significant associations with SZ were next analyzed in relation to neurocognitive measures estimated with a computerized neurocognitive battery in a subset of the sample (n = 116 cases, n = 170 controls). Results: Three variants and one microsatellite showed allelic association with SZ (rs35753505, rs4733263, rs6994992, and microsatellite 420M9-1395, p. ≤. 0.05 uncorrected for multiple comparisons). A six marker haplotype 221121 (rs35753505-rs6994992-rs1354336-rs10093107-rs3924999-rs11780123) showed (p = 0.0004) association after Bonferroni corrections. Regression analyses with the neurocognitive measures showed nominal (uncorrected) associations with emotion processing and attention at rs35753505 and rs6994992, respectively. Conclusions: Suggestive associations with SZ and SZ-related neurocognitive measures were detected with two SNPs from the NRG1 promoter region in a north Indian cohort. The functional role of the alleles merits further investigation. © 2013 Elsevier B.V.


Karbhari P.A.,Cb Patel Research Center | Joshi S.J.,Cb Patel Research Center | Bhoir S.I.,Cb Patel Research Center
Journal of Pharmacy and Bioallied Sciences | Year: 2014

Objective: The aim of the present study is to develop a simple and precise HPLC method for simultaneous determination of thiocolchicoside, aceclofenac and related impurities in a tablet formulation and validate as per ICH guidelines. The aim of study extends to perform forced degradation study to trace the degradation pathways of potential degradant impurities. Materials and Methods: The separation was achieved on a 4.6 mm × 100 mm, 3 μm C 18 column at 40°C with the mobile phase containing 0.1 M ammonium acetate buffer and methanol in a gradient mode at a flow rate of 1.0 mL min-1. The UV detection was carried out at 257 nm. Results: Acelofenac, thiocolchicoside and their related compounds were well separated from each other with good resolution and symmetry factor without interference of excipients. The method for assay was linear in the range of 10-200 μg mL-1 for aceclofenac and 0.4 to 8 μg mL-1 for thiocolchicoside. Conclusion: The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity, robustness, ruggedness and system suitability were met in all cases. The method was highly specific, as two related compounds of thiocolchicoside and nine related compounds of aceclofenac were well separated from each other. Stress study ensured the specificity of the method as the unknown degradation products formed during stress studies did not interfere with the determination of thiocolchicoside and aceclofenac, thus proving the stability indicating capacity of the method.


Varsha N.,Narsee Monjee Institute of Management and Higher Studies | Pratibha V.,Narsee Monjee Institute of Management and Higher Studies | Soni M.,Narsee Monjee Institute of Management and Higher Studies | Ashok B.,Cb Patel Research Center | Suvarna B.,Cb Patel Research Center
Journal of Liquid Chromatography and Related Technologies | Year: 2014

Propylene carbonate (4-methyl-1,3-dioxolan-2-one) is a five-membered cyclic alkylene carbonate with the chemical formula C4H6O 3. It is most commonly used as a solvent for various synthetic polymers and as an electrochemical solvent. Until this date, few RP-HPLC methods have been developed using propylene carbonate as a mobile phase component. This paper aims to further demonstrate the use of Propylene carbonate in RP-HPLC. Three methods have been developed for the simultaneous estimation of Paracetamol and Lornoxicam in combined dosage forms. All these methods use Propylene carbonate as a mobile phase component but in different proportions. Method I is an isocratic RP-HPLC method, Method II uses a solvent gradient program, whereas Method III uses high temperature for the separation of the two drugs. © 2014 Copyright Taylor and Francis Group, LLC.


Joshi S.J.,Cb Patel Research Center | Karbhari P.A.,Cb Patel Research Center | Karbhari P.A.,Ipca laboratories Ltd. | Bhoir S.I.,Cb Patel Research Center | And 2 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2010

A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of bisoprolol fumarate and hydrochlorothiazide in pharmaceutical dosage form. The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on an Inertsil ODS 3V (25 cm × 4.6 mm) 5 μm column with isocratic flow. The mobile phase at a flow rate of 1.0 mL min-1, consisted of 0.1 M potassium dihydrogen phosphate buffer and acetonitrile (70:30, v/v). The UV detection was carried out at 228 nm. A linear response was observed over the concentration range 2.5-50 μg mL-1 of bisoprolol fumarate and the concentration range 6.25-125 μg mL-1 of hydrochlorothiazide. Limit of detection and limit of quantitation for bisoprolol fumarate were 0.01 and 0.03 μg mL-1, respectively and for hydrochlorothiazide were 0.01 and 0.05 μg mL-1, respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, ruggedness and system suitability. Individual drugs (bisoprolol fumarate and hydrochlorothiazide), their combinations and the tablets were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions. The resultant stressed samples were analyzed by the proposed method. The method gave high resolution among the degradation products and the analytes. The peak purity of analyte peaks in the stressed samples was confirmed by photodiode array detector. The method was used for accelerated stability study on marketed and in-house formulations. The analysis concluded that the method was selective for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide and was stability-indicating. © 2009 Elsevier B.V. All rights reserved.


PubMed | Cb Patel Research Center
Type: Journal Article | Journal: Journal of pharmacy & bioallied sciences | Year: 2014

The aim of the present study is to develop a simple and precise HPLC method for simultaneous determination of thiocolchicoside, aceclofenac and related impurities in a tablet formulation and validate as per ICH guidelines. The aim of study extends to perform forced degradation study to trace the degradation pathways of potential degradant impurities.The separation was achieved on a 4.6 mm 100 mm, 3 m C18 column at 40C with the mobile phase containing 0.1 M ammonium acetate buffer and methanol in a gradient mode at a flow rate of 1.0 mL min(-1). The UV detection was carried out at 257 nm.Acelofenac, thiocolchicoside and their related compounds were well separated from each other with good resolution and symmetry factor without interference of excipients. The method for assay was linear in the range of 10-200 g mL(-1) for aceclofenac and 0.4 to 8 g mL(-1) for thiocolchicoside.The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity, robustness, ruggedness and system suitability were met in all cases. The method was highly specific, as two related compounds of thiocolchicoside and nine related compounds of aceclofenac were well separated from each other. Stress study ensured the specificity of the method as the unknown degradation products formed during stress studies did not interfere with the determination of thiocolchicoside and aceclofenac, thus proving the stability indicating capacity of the method.


Varsha N.,Narsee Monjee Institute of Management and Higher Studies | Suvarna B.,Cb Patel Research Center | Pratibha V.,Narsee Monjee Institute of Management and Higher Studies | Soni M.,Narsee Monjee Institute of Management and Higher Studies | Ashok B.,Cb Patel Research Center
Journal of Liquid Chromatography and Related Technologies | Year: 2012

Acetonitrile (ACN), methanol (MeOH), and tetrahydrofuran are the most commonly used organic solvents in RP-HPLC. The present work suggests how ACN in the mobile phase has been efficiently replaced by a new solvent mixture of propylene carbonate (PC) and MeOH in the ratio 60:40 in RP-HPLC method for simultaneous estimation of Alprazolam and Sertraline. Presently, PC is used as a solvent for synthetic polymers and as an electrochemical solvent. However, through the present study, it has been proved that it can also be used as a mobile phase component in RP-HPLC. PC has numerous advantages over ACN with respect to boiling point, flashpoint, biodegradability, clinical toxicity, and so forth. Two RP-HPLC methods have been developed and validated for the simultaneous estimation of Alprazolam and Sertraline in combined dosage forms using both ACN and Solvent-X (PC:Methanol; 60:40), respectively, as a mobile phase component. The two methods are then compared. It is observed that the method developed using Solvent-X is rapid, reproducible, and precise and meets the acceptance criteria for all parameters set by International Conference on Harmonization (ICH). Hence, it is speculated that Solvent-X can be used as a mobile phase component in RP-HPLC for routine qualitative and quantitative analysis in industries. © 2012 Copyright Taylor and Francis Group, LLC.


PubMed | Cb Patel Research Center
Type: Journal Article | Journal: Journal of pharmaceutical and biomedical analysis | Year: 2010

A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of bisoprolol fumarate and hydrochlorothiazide in pharmaceutical dosage form. The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on an Inertsil ODS 3V (25cmx4.6mm) 5microm column with isocratic flow. The mobile phase at a flow rate of 1.0mLmin(-1), consisted of 0.1M potassium dihydrogen phosphate buffer and acetonitrile (70:30, v/v). The UV detection was carried out at 228nm. A linear response was observed over the concentration range 2.5-50microgmL(-1) of bisoprolol fumarate and the concentration range 6.25-125microgmL(-1) of hydrochlorothiazide. Limit of detection and limit of quantitation for bisoprolol fumarate were 0.01 and 0.03microgmL(-1), respectively and for hydrochlorothiazide were 0.01 and 0.05microgmL(-1), respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, ruggedness and system suitability. Individual drugs (bisoprolol fumarate and hydrochlorothiazide), their combinations and the tablets were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions. The resultant stressed samples were analyzed by the proposed method. The method gave high resolution among the degradation products and the analytes. The peak purity of analyte peaks in the stressed samples was confirmed by photodiode array detector. The method was used for accelerated stability study on marketed and in-house formulations. The analysis concluded that the method was selective for simultaneous estimation of bisoprolol fumarate and hydrochlorothiazide and was stability-indicating.

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