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A validated stability-indicating HPLC related substances method for rivastigmine tartrate in bulk drug and dosage form
Sanjay A.Patil,Premchand B.Patil,Devanand B.Shinde,Bhata R.Chaudhari
International Journal of Pharmacy and Biomedical Sciences , 2012,
Abstract: A gradient reverse phase high performance liquid chromatography (RP-HPLC) was developed for the quantitative determination of Rivastigmine tartrate in bulk drugs and in pharmaceutical dosage form. The developed method is stability indicating which separates the drug from degradation products and is also applicable for related substance determination of Rivastigmine tartrate in bulk drug. The chromatographic separation was achieved on a Inertsil sprint C8 column (250 x 4.6mm, 5μ) and the mobile phase containing the mixture of solution-A [acetonitrile and 0.1% of orthophosphoric acid in water (15:85v/v, pH3.2 adjusted by Triethylamine)] and solution-B [acetonitrile and 0.1% of orthophosphoric acid in water (85:15v/v, pH3.2 adjusted by Triethylamine)]. The flow rate of the mobile phase is set at 1.0mL/min. The detection was carried out at wave length 220nm and column oven temperature at 30°C. The chromatographic resolution between its impurities and degraded products was found to be greater than three. Forced degradation studies were performed for Rivastigmine tartrate bulk drug using Acid (4N HCl) Base (3N NaOH), Oxidation (4% H2O2) and 80oC heat. The degradation was observed for Rivastigmine tartrate in Acid, Base and Oxidation. The mass balance of Rivastigmine was close to 100% in all the stress conditions. The developed method was validated with respective linearity, accuracy, precision, roubustness and forced degradation studies prove stability indicating power of the developed method.
STABILITY - INDICATING LC METHOD FOR THE SIMULTANEOUS DETERMINATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE IN DOSAGE FORM
PATIL,KIRAN R; SHINDE,DEVANAND B;
Journal of the Chilean Chemical Society , 2012, DOI: 10.4067/S0717-97072012000100014
Abstract: a simple, rapid, and precise method is developed for the quantitative simultaneous estimation of telmisartan and hydrochlorothiazide in combined pharmaceutical dosage form. a chromatographic separation of the two drugs was achieved with an ace 5 c18 (250 x 4.6 mm) analytical column using buffer-acetonitrile (55:45 v/v). the buffer used in mobile phase contains 0.1m sodium perchlorate monohydrate in double distilled water ph adjusted 3.0 with trifluoroacetic acid. the instrumental settings are flow rate of 1.5 ml min-1, column temperature at 30oc, and detector wavelength of 215 nm using a photodiode array detector. the resolution between hydrochlorothiazide and telmisartan founds to be more than 5. theoretical plates for hydrochlorothiazide and telmisartan were 13022 and 6629 respectively. tailing factor for hydrochlorothiazide and telmisartan was 0.94 and 0.98 respectively. telmisartan, hydrochlorothiazide and their combination drug products stressed samples were analysed by the proposed method. the described method shows excellent linearity over a range of 70 to 130% of target analyte concentration. the correlation coefficient for telmisartan and hydrochlorothiazide are 0.9999. the relative standard deviation for six measurements in two sets of each drug in tablets is always less than 2%. the proposed method was found to be suitable and accurate for quantitative determination and stability study of telmisartan and hydrochlorothiazide in pharmaceutical preparations.
Stability - Indicating LC Method for the Simultaneous Determination of Olmesartan and Ramipril in Dosage Form
Kiran R. Patil,Devanand B. Shinde
International Journal of Industrial Chemistry , 2011,
Abstract: A simple, rapid, and precise method is developed for the quantitative simultaneous estimation of Olmesartan (OL) and Ramipril (RAM) in combined pharmaceutical dosage form. A chromatographic separation was achieved with YMC Pack ODS A (250 x 4.6 mm) analytical column. The mobile phase composed of buffer, acetonitrile and methanol (50:40:10 v/v/v). The buffer used in the mobile phase is 0.1M sodium perchlorate monohydrate in double distilled water and pH adjusted 3.0 with trifluoroacetic acid. The instrumental settings are flow rate of 1.0 mL/min, column oven temperature at 30°C and detector wavelength of 210 nm using a photodiode array detector. The resolution between OL and RAM founds to be more than 4. Theoretical plates for OL and RAM were 16599 and 15900 respectively. Tailing factor for OL and RAM was 1.11 and 1.14 respectively. Capacity factor for OL and RAM was 3.14 and 3.60 respectively. OL, RAM and combination drug product were exposed to thermal, light, hydrolytic and oxidative stress conditions, and the stressed samples were analysed by the proposed method. The proposed method was found to be suitable and accurate for quantitative determination and stability study of OL and RAM in pharmaceutical preparations.
STABILITY - INDICATING LC METHOD FOR THE SIMULTANEOUS DETERMINATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE IN DOSAGE FORM
KIRAN R PATIL,DEVANAND B SHINDE
Journal of the Chilean Chemical Society , 2012,
Abstract: A simple, rapid, and precise method is developed for the quantitative simultaneous estimation of telmisartan and hydrochlorothiazide in combined pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with an ACE 5 C18 (250 x 4.6 mm) analytical column using buffer-acetonitrile (55:45 v/v). The buffer used in mobile phase contains 0.1M sodium perchlorate monohydrate in double distilled water pH adjusted 3.0 with trifluoroacetic acid. The instrumental settings are flow rate of 1.5 ml min-1, column temperature at 30oC, and detector wavelength of 215 nm using a photodiode array detector. The resolution between hydrochlorothiazide and telmisartan founds to be more than 5. Theoretical plates for hydrochlorothiazide and telmisartan were 13022 and 6629 respectively. Tailing factor for hydrochlorothiazide and telmisartan was 0.94 and 0.98 respectively. Telmisartan, hydrochlorothiazide and their combination drug products stressed samples were analysed by the proposed method. The described method shows excellent linearity over a range of 70 to 130% of target analyte concentration. The correlation coefficient for telmisartan and hydrochlorothiazide are 0.9999. The relative standard deviation for six measurements in two sets of each drug in tablets is always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of telmisartan and hydrochlorothiazide in pharmaceutical preparations.
MICROWAVE-ASSISTED SYNTHESIS OF BENZOFURAN ANALOGS OF FENAMATES AS NON STEROIDAL ANTI-INFLAMMATORY AGENTS
MANE,BALASAHEB Y; AGASIMUNDIN,Y.S; SHIVKUMAR,B; SHINDE,DEVANAND B;
Journal of the Chilean Chemical Society , 2009, DOI: 10.4067/S0717-97072009000100018
Abstract: a series of benzofuran analogs of anthranilic acid derivatives were easily synthesized by microwave irradiation and conventional heating method. the microwave irradiation method gives the comparable yield as that of conventional heating with a shorter reaction time. all the new compounds have been characterized by spectral data and screened for anti-inflammatory activity.
MICROWAVE-ASSISTED SYNTHESIS OF BENZOFURAN ANALOGS OF FENAMATES AS NON STEROIDAL ANTI-INFLAMMATORY AGENTS
BALASAHEB Y MANE,Y.S AGASIMUNDIN,B SHIVKUMAR,DEVANAND B SHINDE
Journal of the Chilean Chemical Society , 2009,
Abstract: A series of benzofuran analogs of anthranilic acid derivatives were easily synthesized by microwave irradiation and conventional heating method. The microwave irradiation method gives the comparable yield as that of conventional heating with a shorter reaction time. All the new compounds have been characterized by spectral data and screened for anti-inflammatory activity.
Stability-indicating HPLC determination of pramipexole dihydrochloride in bulk drug and pharmaceutical dosage form
Panditrao, Vedavati M;Sarkate, Aniket P;Sangshetti, Jaiprakash N;Wakte, Pravin S;Shinde, Devanand B;
Journal of the Brazilian Chemical Society , 2011, DOI: 10.1590/S0103-50532011000700009
Abstract: a novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for quantitative determination of pramipexole dihydrochloride in bulk drugs and in pharmaceutical dosage form in the presence of degradation products. an isocratic, reversed phase hplc method was developed to separate the drug from the degradation products, using an ace5-c18 (250×4.6 mm, 5 μm) advance chromatography column, and 10 mmol l-1 ammonium acetate and acetonitrile (75:25 v/v) as a mobile phase. the detection was carried out at a wavelength of 260 nm. the pramipexole was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. degradation was observed for pramipexole in base, in acid and in 30% h2o2. the drug was found to be stable in the other stress conditions attempted. the degradation products were well resolved from the main peak. the percentage recovery of pramipexole was from (99.87 to 99.98%) in the pharmaceutical dosage form. the developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, specificity and robustness. the forced degradation studies prove the stability indicating power of the method.
VALIDATED CHIRAL LC METHOD FOR DEXRABEPRAZOLE ON REVERSE PHASE AMYLOSE BASED STATIONARY PHASE
PATIL,KIRAN R; RANE,VIPUL P; YEOLE,RAVINDRA D; SANGSHETTI,JAIPRAKASH N; SHINDE,DEVANAND B;
Journal of the Chilean Chemical Society , 2011, DOI: 10.4067/S0717-97072011000200018
Abstract: a simple, rapid and robust lc method was developed and validated for the enantiomeric separation of dexrabeprazole in bulk drug and formulation. the enantiomers of dexrabeprazole were resolved on a chiralpak ad-rh (amylose based stationary phase) column using a mobile phase consisting of water: acetonitrile (50:50, v/v) at a flow rate of 0.5 ml min1. the resolution between the enantiomers was found to be more than 1.5 in optimized method. the developed method was extensively validated and proved to be robust. the calibration curve for (s)-enantiomer showed excellent linearity over the concentration range of 0.05 μg ml1 (loq) to 1 μg ml1. the limit of detection and limit of quantification for (s)-enantiomer were 0.015 μg ml1 and 0.05 μg ml1, respectively. the percentage recovery of the (s)-enantiomer ranged between 97 to 101 % in bulk drug samples of dexrabeprazole. the proposed method was found to be suitable and accurate for quantitative determination of (s)-enantiomer in bulk drug substance.
Optimization of process variables for phyllanthin extraction from Phyllanthus amarus leaves by supercritical fluid using a Box-Behnken experimental design followed by HPLC identification
BHUSARI, SACHIN S.,PATIL, AJIT A.,SHINDE, DEVANAND B.,WAKTE, PRAVIN S.
- , 2013, DOI: 10.2478/acph-2013-0020
Abstract: Sa？etak The response surface methodology using the Box-Behnken design was established to describe supercritical carbon dioxide assisted extraction of phyllanthin from Phyllanthus amarus Schum and Thonn leaves prior to HPLC analysis. The effects of extraction pressure, temperature, modifier concentration and extraction time on the yield of phyllanthin were investigated. By solving the regression equation, the optimum conditions were as follows: extraction pressure 23.2 MPa, temperature 40 °C, methanol as modifier at a concentration 10 % and time 90 min. Under these conditions, the phyllanthin yield was 12.83 ± 0.28 mg g-1, which was in good agreement with the predicted values. Modifier concentration and extraction time showed a significant effect on the phyllanthin yield
Ceric ammonium nitrate catalysed three component one-pot efficient synthesis of 2,4,5-triaryl-1H-imidazoles
Devanand B Shinde,Jaiprakash N Sangshetti,Nagnnath D Kokare,Sandeep A Kotharkara
- , 2008,
Abstract:
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