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Khan, Hamid
- Validated HPLC-UV Method for Simultaneous Determination of Some Anti-Inflammatory and Analgesic Drugs
Authors
1 JK College of Pharmacy, Bilaspur, CG-495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 6, No 3 (2016), Pagination: 183-187Abstract
In the presented work identification and quantification of some anti-inflammatory and analgesic drugs, namely aceclofenac, diclofenac, paracetamol and para-aminophenol were carried out by validated HPLC-UV method. The chromatographic separation was achieved on HPLC C18 (100.0 × 2.1 mm, 1.7μm) column using isocratic mobile phase consisting of acetonitrile-phosphate buffer (50:50, v/v) at a flow rate of 1.0 mL/min. The UV detection was carried out at 275 nm for all the compounds. The elution of aceclofenac, diclofenac, paracetamol and para-aminophenol was occurred at 7.0, 9.2, 2.0 and 4.2 min, respectively. The calibration curves were linear over the concentration range of 1-1000 μg/mL for aceclofenac and paracetamol, and 1-100 μg/mL for diclofenac and para-aminophenol. The developed method was validated according to ICH guidelines. The method was applied in the identification and quantitative determination of these compounds during routine quality control analysis and in stability studies.Keywords
HPLC-UV, Aceclofenac, Paracetamol, Diclofenac, Para-Aminophenol, Validation.- Fixed Dose Combination (FDC) Products:Introduction, Development and Regulations
Authors
1 JK College of Pharmacy, Bilaspur, CG-495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN
Source
Research Journal of Pharmaceutical Dosage Form and Technology, Vol 8, No 3 (2016), Pagination: 207-210Abstract
A fixed dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Combination therapy with two or more agents having complementary mechanisms of action represents a type of incremental innovation that has extended the range of therapeutic options in the treatment of almost every human disease. Combining two or more active pharmaceutical ingredients in a single-dosage form can increase a drug's efficacy and improve patient compliance. Several difficulties arise during formulation development, manufacturing and regulations of FDC products. Two or more active ingredients in the FDCs must be physically and chemically compatible along with their excipients. In this review article authors provided the brief information regarding advantages, formulation development and regulations of FDC products.- Formulation and In-Vitro Evaluation of In-Lay Matrix Tablets Containing Telmisartan and Hydrochlorothiazide
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Jamia Hamdard, New Delhi 110062, IN
Source
Research Journal of Pharmaceutical Dosage Form and Technology, Vol 7, No 3 (2015), Pagination: 193-198Abstract
The aim of the presented work was formulation and in-vitro evaluation of in-lay tablets containing telmisartan as sustained release outer core and hydrochlorothiazide as immediate release inner core using HPMC and co-polymer carbopol 71G. Tablets were evaluated via various quality control tests and in-vitro drug release studies. Drug release study was carried out hydrochloric acid buffer of pH 1.2 (0.1N) using USP paddle apparatus. The validated HPLC-UV method was applied to determine the amount of drugs released at different time intervals. The mechanism of drug release through polymeric network was established. Prepared tablets showed extended sustain release of telmisartan over a period of 20 h and hydrochlorothiazide as immediate release within 30 min.Keywords
In-Lay Tablet, Telmisartan, Hydrochlorothiazide, Sustained Release, Immediate Release.- Identification of Impurities and Degradation Products in Pharmaceutical Products-Role of Hyphenated Techniques
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, -110062, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 1 (2017), Pagination: 31-35Abstract
Impurity profiling and identification of degradation product is an essential part of pharmaceutical development program. Impurity profiling is mandatory requirement by various regulatory agencies and is directly related with the quality, safety and efficacy of a drug product. The ultimate purpose of impurity profiling and stress testing is in the establishment of the degradation products pathways and to investigate the stability-indicating power of the analytical procedures which is ultimately helpful in the prediction of shelf life of drug product. Hyphenated technique is combination a combination of two different analytical techniques with the help of proper interface. Mainly chromatographic techniques are combined with the spectroscopic techniques. This write up provides a review on brief information about role of different hyphenated analytical techniques such as HPLC-UV, HPLCMS, GC-MS and UPLC-MS/MS for identification of impurities and degradation products in pharmaceutical products.Keywords
Identification, Impurities, Degradation Products, Stress Testing, Analytical Techniques.- Validated UPLC/Q-TOF-MS Method for Simultaneous Determination of Aceclofenac, Paracetamol and Chlorzoxazone in Human Plasma and its Application to Pharmacokinetic Study
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 2 (2017), Pagination: 93-99Abstract
In the presented work the ultra-performance liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC/Q-TOF-MS) method has been developed for pharmacokinetic study of some antiinflammatory and analgesic drugs in human plasma. The aceclofenac, paracetamol, and chlorzoxazone were analyzed by Acquity UPLC BEH C18 (100.0_2.1 mm, 1.7 lm) column using isocratic mobile phase consisting of acetonitrile-2mM ammonium acetate (50:50, v/v) at a flow rate of 0.20 mL/min. The Q-TOF mass spectrometer was operated in positive ionization mode and quantization was done using the MS/MS transitions m/z 354.07 to 215.07 for aceclofenac, 152.07 to 110.06 for paracetamol and 170.00 to 134.00 for chlorzoxazone. The calibration curves were linear over the concentration range of 1-1000 ng/mL for all the drugs. The developed method was validated according to ICH guidelines. The method was applied for pharmacokinetic study of tablets containing aceclofenac, paracetamol, and chlorzoxazone in human plasma.Keywords
UPLC/Q-TOF-MS, Aceclofenac, Paracetamol, Chlorzoxazone, Pharmacokinetic Study.- UHPLC:Applications in Pharmaceutical Analysis
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 2 (2017), Pagination: 124-131Abstract
High Performance Liquid Chromatography (HPLC) is a major analytical technique for qualitative and quantitative drug analysis. More than 90% of drugs prescribed in official pharmacopoeias are being analyzed HPLC. But due to the higher regulatory requirements such as more number of samples, speed of analysis, and sensitivity of the method of analysis. The pharmaceutical industries adopting the more advanced chromatographic techniques. Ultra-high Performance Liquid Chromatography (UHPLC) offers an advancement of HPLC which is based on the principal of use of stationary phase consisting of particles less than 2μm. By using smaller particles, speed of analysis, peak capacity can be extended to new limits and the sample can be analyzed in a shorter period of time. The UHPLC technique is a new approach in the chromatographic separations and has been successfully employed for fast, high resolution separations with required sensitivity. This review provides the brief introduction and applications of UHPLC in the pharmaceutical analysis.Keywords
UHPLC, UPLC, Introduction, Applications, Pharmaceutical Analysis.- Application of Validated UPLC/Q-TOF-MS Method for Simultaneous Determination of Telmisartan, Hydrochlorothiazide and their Degradation Products in Tablets
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN
Source
Asian Journal of Research in Pharmaceutical Sciences, Vol 7, No 2 (2017), Pagination: 105-111Abstract
In the presented work the ultra-performance liquid chromatography/ quadrupole time-of-flight mass spectrometric (UPLC/Q-TOF-MS) method is developed for simultaneous determination of telmisartan, hydrochlorothiazide and their degradation products in tablets. For identification of drugs, the Q-TOF mass spectrometer was operated in negative ionization mode and quantification was done using the MS/MS transitions at m/z 513.18 to 469.13 for telmisartan, and 268.90 to 204.94 for hydrochlorothiazide. For quantification, the chromatographic separation was achieved on Acquity UPLCTM BEH C18 (100.0 × 2.1 mm, 1.7μm) column using isocratic mobile phase consisting of acetonitrile-2mM ammonium acetate (50:50, v/v) at a flow rate of 0.25 mL/min. The elution of telmisartan and hydrochlorothiazide was occurred at 2.25 and 1.22 min, respectively. The calibration curves were linear over the concentration range of 1-1000 ng/mL for both the drugs. The developed method was validated according to ICH guidelines.Keywords
UPLC/Q-TOF-MS, Telmisartan, Hydrochlorothiazide, Validation, Degradation Study.- Validated UPLC/Q-TOF-MS Method for Simultaneous Determination of Metformin, Glimepiride and Pioglitazone in Human Plasma and its Application to Pharmacokinetic Study
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN
Source
Asian Journal of Pharmacy and Technology, Vol 7, No 1 (2017), Pagination: 27-32Abstract
In the presented work the ultra-performance liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC/Q-TOF-MS) method has been developed for simultaneous determination of metformin, glimepiride and pioglitazone in human plasma. For identification of drugs, the Q-TOF mass spectrometer was operated in positive ionization mode and quantification was done using the MS/MS transitions at m/z 130.0 to 71.0 for metformin, 491.00 to 352.00 for glimepiride and 357.00 to 134.00 for pioglitazone. The chromatographic separation was achieved on Acquity UPLCTM BEH C18 (100.0 × 2.1 mm, 1.7μm) column using isocratic mobile phase consisting of acetonitrile-2mM ammonium acetate (50:50, v/v) at a flow rate of 0.20 mL/min. The elution of metformin, glimepiride and pioglitazone was occurred at 0.50, 1.40 and 1.22 min, respectively. The calibration curves were linear over the concentration range of 1-1000 ng/mL for all the drugs. The developed method was validated according to ICH guidelines. The method was applied for pharmacokinetic study of drugs in FDC tablets in human plasma.
Keywords
UPLC/Q-TOF-MS, Metformin, Glimepiride, Pioglitazone, FDC Tablets, Pharmacokinetic Study.- Formulation and Evaluation of Sustained Release Matrix Tablets Containing Aceclofenac and Paracetamol
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN
Source
Research Journal of Pharmaceutical Dosage Form and Technology, Vol 9, No 2 (2017), Pagination: 48-52Abstract
The sustained release matrix tablets were formulated and evaluated by wet granulation method. Tablets were formulated using hydrophilic polymer and binder, HPMC K100 and PVP respectively. In-vitro drug release studies were carried out in hydrochloric acid buffer of pH 1.2 (0.1N) with 1% w/v SLS using USP paddle apparatus. The amount of drugs released at different time intervals were determined by validated UPLC-PDA method. In-vitro drug release from prepared tablets showed better sustained release effect when compared with marketed combination tablets. Tablets thus formulated provided extended release of aceclofenac and paracetamol over the period of 6 h.Keywords
Aceclofenac, Paracetamol, Sustained Release, Matrix Tablets, HPMC.- Formulation and In-Vitro Evaluation of a Sustained Release Matrix Tablet of Telmisatan
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 10062, IN
Source
Research Journal of Pharmaceutical Dosage Form and Technology, Vol 9, No 1 (2017), Pagination: 19-23Abstract
The formulation and in-vitro evaluation of matrix tablets containing telmisartan as sustained release using low viscosity grade HPMC as the matrix forming hydrophilic polymer by wet granulation method. The tablets were subjected to in-vitro drug release study in hydrochloric acid buffer of pH 1.2 (0.1N) with 1% w/v SLS using USP paddle apparatus. The drug released at various time intervals were determined by validated UPLC-PDA method. The prepared tablets showed better sustained release effect when compared with marketed tablets. The drug release mechanism from hydrophilic polymer was proposed. The formulated tablets provided sustained release of telmisartan over a period of 24 h.Keywords
Matrix Tablet, Telmisartan, HPMC, Hydrophilic Polymer, Sustained Release.- Formulation and In-Vitro Evaluation of FDC Bilayer Matrix Tablets Containing Telmisartan as Sustained Release and Hydrochlorothiazide as Immediate Release
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Jamia Hamdard, New Delhi, 110062, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1085-1090Abstract
The aim of the presented work was formulation and in-vitro evaluation of bilayer tablets containing telmisartan as sustained release (SR) and hydrochlorothiazide as immediate release (IR) using HPMC. Tablets were evaluated via various quality control tests and in-vitro drug release studies. Drug release study was carried out hydrochloric acid buffer of pH 1.2 (0.1N) using USP paddle apparatus. The validated HPLC-UV method was applied to determine the amount of drugs released at different time intervals. Prepared tablets showed extended sustain release of telmisartan over a period of 20 h and hydrochlorothiazide as immediate release within 30 min.Keywords
Bilayer Tablet, Telmisartan, Hydrochlorothiazide, Sustained Release, Immediate Release.- Application of Validated HPTLC Method for Dissolution Study of FDC Tablets Containing Telmisartan and Hydrochlorothiazide
Authors
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN
3 Department of Pharmacognosy and Phytochemistry, Hamdard University, New Delhi-110062, IN
Source
Research Journal of Pharmacy and Technology, Vol 10, No 4 (2017), Pagination: 1149-1154Abstract
A simple, selective, precise and HPTLC method for simultaneous determination of telmisartan and hydrochlorothiazide in the bulk drugs and in their fixed dose combination tablets (FDC) was developed and validated. The method was further applied in the dissolution study of formulated and marketed tablets containing these two drugs. The method employed HPTLC aluminium plates precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of toluene-ethyl acetate-methanol-glacial acetic acid, 6: 3: 1: 0.5 (v/v). The detection was performed at 272 nm. The RF values were 0.70 ± 2 for telmisartan and 0.44 ± 2 for hydrochlorothiazide. The linear relationships were obtained between peak area and amount of drugs in the range of 1-1000 ng spot-1 with correlation coefficient of 0.9992 for telmisartan and 0.9994 for hydrochlorothiazide. The method was validated for precision, robustness and recovery. The limits of detection and quantification were 15.54 and 48.44 ng spot-1 for telmisartan and 10.22 and 35.68 ng spot-1 for hydrochlorothiazide, respectively. Invitro drug release from prepared tablets showed better drug release when compared with marketed tablets.Keywords
Telmisartan, Hydrochlorothiazide, HPTLC, Dissolution Study.- Analytical Method Development in Pharmaceutical Research:Steps Involved in HPLC Method Development
Authors
1 J K College of Pharmacy, Bilaspur-495001, CG, IN