Torrent Research Center

Gujarat, India

Torrent Research Center

Gujarat, India
SEARCH FILTERS
Time filter
Source Type

Patel A.H.,Torrent Research Center | Patel J.K.,P.A. College | Patel K.N.,P.A. College
International Journal of Pharmaceutical Sciences | Year: 2010

The use of first order derivative spectroscophotometry allowed simultaneous determination of domperidone and rabeprazole sodium, in fixed dose combination products. The absorbance values at 253.2 nm and 266.4 nm of first derivative spectrum was used for the estimation of domperidone and rabeprazole sodium, respectively without mutual interference. This method obeyed beer's law in the concentration range of 9-45 μg/ml and 6-30 μg/ml for both domperidone and rabeprazole sodium, respectively. The results of analysis have been validated statistically and recovery studies confirmed the accuracy of the proposed method.


Patel A.H.,Torrent Research Center | Patel J.K.,P.A. College | Patel K.N.,P.A. College
International Journal of Pharmaceutical Sciences | Year: 2010

The use of first order derivative spectroscophotometry allowed simultaneous determination of domperidone and rabeprazole sodium, in fixed dose combination products. The absorbance values at 253.2 nm and 266.4 nm of first derivative spectrum was used for the estimation of domperidone and rabeprazole sodium, respectively without mutual interference. This method obeyed beer's law in the concentration range of 9-45 μg/ml and 6-30 μg/ml for both domperidone and rabeprazole sodium, respectively. The results of analysis have been validated statistically and recovery studies confirmed the accuracy of the proposed method.


Patel A.H.,Torrent Research Center | Captain A.D.,Institute Of Science And Technology For Advance Research Istar
Journal of Young Pharmacists | Year: 2010

Two methods are described for determination of Doxophylline in a solid dosage form. The first method was based on ultraviolet (UV)-spectrophotometric determination of the drug. It involves absorbance measurement at 274 nm ( max of Doxophylline) in 0.1 N hydrochloric acid. The calibration curve was linear, with the correlation coefficient between 0.99 and 1.0 over a concentration range of 0.20-30 mg/ml for the drug. The second method was based on high-performance liquid chromatography (HPLC) separation of the drug in reverse-phase mode using the Hypersil ODS C 18 column (250 X 4.6 mm, 5 mm). The mobile phase constituted of buffer acetonitrile (80:20) and pH adjusted to 3.0, with dilute orthophosphoric acid delivered at a flow rate 1.0 ml/min. Detection was performed at 210 nm. Separation was completed within 7 min. The calibration curve was linear, with the correlation coefficient between 0.99 and 1.0 over a concentration range of 0.165-30 mg/ml for the drug. The relative standard deviation was found to be <2.0% for the UV-spectrophotometry and HPLC methods. Both these methods have been successively applied to the solid dosage pharmaceutical formulation, and were fully validated according to ICH guidelines.


Mehta S.,Torrent Research Center | Singh S.,Torrent Research Center | Chikhalia K.,Gujarat University
Scientia Pharmaceutica | Year: 2014

A robust, sensitive, and stability-indicating rapid resolution liquid chromato-graphy method for the simultaneous determination of process impurities and degradation products of lercanidipine hydrochloride in pharmaceutical dosage form was developed and validated. The chromatographic separation was performed on the Zorbax SB C18 [(50 × 4.6) mm] 1.8 μm column, using gradient elution of a potassium dihydrogen phosphate buffer (pH 3.5, 0.01 M) and acetonitrile. The flow rate was 1.0 ml/min and UV detection was performed at 220 nm. The method was further evaluated for its stability-indicating capability by hydrolytic, oxidative, thermal, thermal with moisture, and photolytic degradation studies. All acceptance criteria of the International Conference on Harmonization guidelines for validation were covered in the method validation. This method can be used for purity control during manufacture and real time stability studies. A shorter run time of 10 minutes and good solution stability for at least 48 hours allowed the quantification of more than 50 samples per day with comparatively lower costs than existing methods. © Mehta et al.


Singh S.,Torrent Research Center | Gadhawala Z.,University of Rajasthan
International Journal of PharmTech Research | Year: 2013

A simple, sensitive and reproducible reversed phase rapid resolution liquid chromatography (RPRRLC) coupled with a photodiode array detector method was developed and validated for determination of Allopurinol and its related substances in pharmaceutical dosage forms. The chromatographic separation was achieved on Zorbax SB C8 (1.8μm, 4.6mm X 50mm) column using gradient elution of potassium dihydrogen phosphate buffer (pH 2.50, 0.025M) and methanol at flow rate of 1.0 ml/min. UV detection was performed on 230 nm. Total run time was 10 min within which main compound and other known and unknown impurities were separated. Stability indicating capability was established by force degradation experiments and separation of known degradation products. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, LOQ and LOD were established for Allopurinol and its known impurities.


Joshi D.,Torrent Research Center | Shiwalkar A.,Torrent Research Center | Cross M.R.,Veeda Clinical Research | Sharma S.K.,Veeda Clinical Research | And 2 more authors.
Heart | Year: 2010

Background: Reduced exercise capacity in diabetics has been attributed to limitations in cardiac function and microvascular dysfunction leading to impaired oxygen supply and nutritive perfusion to exercising muscles. Objective: To study changes in cardiac function and microvascular utilisation during exercise in diabetic individuals compared to age-matched controls. Methods: Diabetics with glycosylated haemoglobin (HbA1c) <8 (n=31), diabetics with HbA1c ≥8 (n=38) and age-matched non-diabetic controls (n=32) performed exercise at 50 W for 10 minutes followed by recovery, with continuous monitoring of cardiac function by impedance cardiography and regional flow and oxygen saturation by laser Doppler and white light spectroscopy. Results: In the diabetics, cardiac reserve during exercise and cardiac overshoot during recovery are significantly reduced because of reduction in capacity to increase stroke volume. Regional flow to the exercising muscle is reduced and there is also disproportionately greater desaturation of the regional flow. Abnormalities in cardiac function and regional perfusion are related to the severity of diabetes. Conclusion: Cardiac response to exercise is attenuated significantly in diabetic individuals. Simultaneously, there is impairment in the regional distribution. These changes could be the harbinger of reduced exercise capacity in diabetics.


Bansal V.,Torrent Research Center | Malviya R.,Galgotias University | Deeksha,Galgotias University | Malaviya T.,Allahabad University | Sharma P.K.,Galgotias University
Global Journal of Pharmacology | Year: 2014

Bauhinia variegata Linn is a widely used medicinal plant distributed in the tropical regions throughout the world. Its various part i.e. flowers, flower buds, stem, roots, stem bark, seeds, leaves have been used since ancient times for the treatment of a large range of diseases such as dysentery, diarrhoea, haemorrhoids, piles, oedema, laxative, anthelmintic, astringent, antileprotic, wound healing, antigoitrogenic, antitumor, antidote for snake poisoning, dyspepsia, carminative etc. The plant contains several flavonoids, steroids, glycosides, reducing sugars as active constituents that bring about its biological effects. Preclinical (invivo and invitro) investigations have demonstrated pharmacological activities such as antioxidant, hypolipidemic, immunomodulatory, anti-inflammatory, anti-microbial, insecticidal, antibacterial, antidiabetic, antiulcer, hepatoprotective, anti-arthritic, anti-mutagenic, cytotoxic, trypsin inhibitor, anti-goitrogenic. The present review is an attempt to compile information on various ethnomedical aspects, morphology, microscopy, phytochemical studies, pharmacological studies and its ayurvedic preparation, to explain the multifaceted role of this medicinal plant. © IDOSI Publications, 2014.


Chokshi N.,Torrent Research Center
Journal of Generic Medicines | Year: 2011

Pharmaceutical market in Japan is the largest in Asia by value. ICH comprises three developed regions namely USA, Europe, and Japan. Though majority of regulations are harmonized, Japan's regulations are yet less explored compared to USA and Europe perhaps due to language barriers. Sharing of vital technological information to the drug product manufacturer remains a cause of concern to the manufacturers of ingredients and packaging components. Master files are voluntary vehicles for conveying product and manufacturing information from suppliers and contractors directly to regulators to support new drug and biologic product review, and may have open and closed sections. The latter contains confidential information for regulator's reference. Japan has master file systems that accommodate a broader range of drug and components like packaging materials. Japan added a master file system similar to the US model by updating its regulatory process under the 2005 Pharmaceutical Affairs Law. The accreditation of manufacturing facility is one of the very unique features of master file system as unlike US and Europe, for Japan facility approval process starts well before the submission of the actual drug master file. The stability requirements involve more sample analysis compared to the other international regulatory compliance requirements. Point has to be noted that data equivalent to module 2 of common technical document and application form are required to be translated in Japanese language. However, the quality section (module 3) can be submitted in English language. Understanding of master file system is important for companies entering into the Japanese market. The master file system of Japan is discussed in this article. © The Author(s) 2011.


Mane U.R.,M. S. University of Baroda | Mane U.R.,Torrent Research Center | Gupta R.C.,Torrent Research Center | Nadkarni S.S.,Torrent Research Center | And 3 more authors.
Expert Opinion on Therapeutic Patents | Year: 2013

Introduction: There is an urgent need to discover new antimalarial drugs due to emergence of resistance in the parasite to the existing drugs. Malarial cysteine proteases falcipin-2 (FP-2) and falcipain-3 (FP-3) are attractive targets for antimalarial chemotherapy. The structures and functions of FP-2/3, their binding domains and their interactions with small- and macro-molecules are well studied. These studies could provide important insight into rational designing of FP inhibitors as potential antimalarial drugs. Areas covered: This review is focused on a selection of interesting patents published during 1999-2011 on peptidic and nonpeptidic chemotypes of the FP-2/FP-3 inhibitors. Expert opinion: It is a known fact that malaria is a serious health problem worldwide due to the emergence of resistant strains. Hence, development of novel, potent and affordable antimalarial drugs devoid of side effects is of great significance and in great demand. FPs, the malarial cysteine proteases are potential targets for development of new antimalarial drugs. Assessing the available literature on FP-2/3 and their inhibitors it could be speculated that these inhibitors have the potential to enter the clinical stages of development for the treatment of malaria in the years to come. © 2013 Informa UK, Ltd.


Chokshi N.A.,Torrent Research Center
Journal of Generic Medicines | Year: 2013

Prior to Pediatric Research Equity Act's enactment, Food and Drug Administration had approved several suitability petitions to permit abbreviated new drug applications to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference-listed drugs. Pediatric Research Equity Act does not impose pediatric assessment requirements on abbreviated new drug applications for generic drugs. However, abbreviated new drug applications submitted under an approved suitability petition under section 505(j)(2)(C) of the Act and the said difference from the reference-listed drugs are subject to the pediatric assessment requirements that Pediatric Research Equity Act imposes. In the federal notice dated 23 February 2007, Food and Drug Administration explained that the approval of 128 suitability petitions was being withdrawn because abbreviated new drug applications were never submitted and Pediatric Research Equity Act requires that all applications submitted on or after 1 April 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration containing an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. Underlining information in this article helps in understating the Pediatric Research Equity Act, pediatric assessment for suitability petitions, pediatric review committee and its role, types of pediatric waivers, and its importance in suitability petitions. Also there are several examples provided for the Pediatric Research Equity Act assessment in recently filed suitability petitions by the various firms. © SAGE Publications.

Loading Torrent Research Center collaborators
Loading Torrent Research Center collaborators