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S. C. Dhiman , Alka Ahuja , Deepti Sharma

Abstract

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Hamid Khan ¹, Mushir Ali ¹, Alka Ahuja ¹, Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG-495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN

Abstract

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.

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Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Jamia Hamdard, New Delhi 110062, IN

Abstract

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.

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Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN

Abstract

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.

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Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN

Abstract

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 UPLC^TM 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.

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Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN

Abstract

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 UPLC^TM 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.

Full Text

     

Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Jamia Hamdard, New Delhi, 110062, IN

Abstract

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.

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Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ², Sayeed Ahmad ³

Affiliations
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

Abstract

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 R_F 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.

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