Prashant Devrukhakar | NIPER (National Institute of Pharmaceutical Education and Research) (original) (raw)
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Papers by Prashant Devrukhakar
Journal of Liquid Chromatography & Related Technologies, 2012
Polypill is a fixed dose combination, used as a single daily pill to achieve a large effect in pr... more Polypill is a fixed dose combination, used as a single daily pill to achieve a large effect in preventing cardiovascular disease with minimal adverse effects. In the present study, gradient LC method was developed for simultaneous determination of the Polycap, that is, Atenolol, Hydrochlorothiazide, Aspirin, Ramipril, and Simvastatin, in presence of their major interaction/degradation products. The individual drug components and their major interaction/degradation products were well separated using reverse phase C18 column and a mobile phase containing Acetonitrile:Phosphate buffer (pH 2.3). Other instrumental parameters were flow rate, 1 mL min−1; detection wavelength, 230 nm; column oven temperature, 40°C; and injection volume, 5 µL. The combined drugs were subjected to stress conditions such as hydrolysis, oxidation, photolysis, and thermal decomposition. The method was validated for linearity, precision, accuracy, specificity, and robustness.
A simple, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxi... more A simple, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) was developed and validated with the help of a suitable statistical soware as an application tool for the quality by design. e drugs individually, and in combination, were subjected to forced degradation (thermal, photolytic, hydrolytic, and oxidative stress conditions) and accelerated stability studies (40 ± 1 ∘ C/75 ± 3% RH for three months). Successful separation of combined drugs from degradation products was achieved by gradient elution on a reverse-phase C18 column, using a mobile phase containing phosphate buffer (pH 3.5): acetonitrile at 1.5 mL min −1 �ow rate, detection wavelength 256 nm, column oven temperature 25 ∘ C, and injection volume 10 L. Linearity was established in the range of 20-300 g mL −1 , 24.5-367.5 g mL −1 and 60-900 g mL −1 for FTC, TDF, and EFV, respectively. e method was successfully applied for quantifying the drugs in marketed dosage forms and on stability samples.
A novel, sensitive and precise UHPLC method has been developed and validated for the simultaneous... more A novel, sensitive and precise UHPLC method has been developed and validated for the simultaneous determination of the all the active components of a Polypill viz Zycad, i.e., Aspirin (ASP) Atorvastatin (ATV), Ramipril (RMP) and Metoprolol (MTP) in Zycad tablet dosage form in the presence of degradation products. Forced degradation of individual as well as combination of all the drug substances components of Polypill was conducted in accordance with ICH guidelines. Acidic, basic, neutral, and oxidative hydrolysis, thermal stress, and photolytic degradation were used to assess the stability-indicating power of the method. Use of 100 × 2.1 mm, 1.7 µm stationary phases with simple mobile phase combination buffer consisting of 0.1% Perchloric acid (adjusted to pH 2.5) and Acetonitrile, delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 215 nm with a flow rate of 0.6 mL·min -1 . The method was optimized using samples generated by forced degradation studies. The method was validated for linearity, accuracy (recovery), precision, Specificity and robustness. The method was linear in the range of 37.5 to 150.0 µg·mL -1 for ASP, 5.0 to 20.0 µg·mL -1 for ATV and 2.5 to 10.0 µg·mL -1 for RMP and 25.0 to 100.0 µg·mL -1 for MTP.
Polypill is a fixed-dose combination (FDC) containing three or more drugs in a single pill with t... more Polypill is a fixed-dose combination (FDC) containing three or more drugs in a single pill with the intention of reducing the number of tablets or capsules that need to be taken. Developing a single analytical method for the estimation of individual drugs in a Polypill is very challenging, due to the formation of drug-drug and drug-excipients interaction impurities. Here an attempt was made to develop a new, sensitive, single stability-indicating HPLC method for the simultaneous quantitative determination of Aspirin (ASP) Atorvastatin (ATV), Atenolol (ATL) and Losartan potassium (LST) in a polypill form in the presence of degradation products. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination of buffer and Acetonitrile. Buffer consists of 0.1% Orthophosphoric acid (pH 2.9), delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 230 nm with a flow rate of 1.0 mL/min. The retention times of Atenolol, Aspirin, Losartan potassium, and Atorvastatin were 3.3, 7.6, 10.7 and 12.9 min respectively. The combination drug product are exposed to thermal, acid/base hydrolytic, humidity and oxidative stress conditions, and the stressed samples were analyzed by proposed method. The method was validated with respect to linearity; the method was linear in the range of 37.5 to 150.0 µg/mL for ASP, 5.0 to 20.0 µg/mL for ATV and 25.0 to 100.0 µg/mL for ATL and LST. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. The validated method was successfully applied to the analysis of Starpill tablets constituting all the four drugs; the percentage recoveries obtained were 99.60% for ASP, 99.30% for ATV, 99.41% for ATL and 99.62% for LST.
Journal of Liquid Chromatography & Related Technologies, 2012
Polypill is a fixed dose combination, used as a single daily pill to achieve a large effect in pr... more Polypill is a fixed dose combination, used as a single daily pill to achieve a large effect in preventing cardiovascular disease with minimal adverse effects. In the present study, gradient LC method was developed for simultaneous determination of the Polycap, that is, Atenolol, Hydrochlorothiazide, Aspirin, Ramipril, and Simvastatin, in presence of their major interaction/degradation products. The individual drug components and their major interaction/degradation products were well separated using reverse phase C18 column and a mobile phase containing Acetonitrile:Phosphate buffer (pH 2.3). Other instrumental parameters were flow rate, 1 mL min−1; detection wavelength, 230 nm; column oven temperature, 40°C; and injection volume, 5 µL. The combined drugs were subjected to stress conditions such as hydrolysis, oxidation, photolysis, and thermal decomposition. The method was validated for linearity, precision, accuracy, specificity, and robustness.
A simple, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxi... more A simple, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and efavirenz (EFV) was developed and validated with the help of a suitable statistical soware as an application tool for the quality by design. e drugs individually, and in combination, were subjected to forced degradation (thermal, photolytic, hydrolytic, and oxidative stress conditions) and accelerated stability studies (40 ± 1 ∘ C/75 ± 3% RH for three months). Successful separation of combined drugs from degradation products was achieved by gradient elution on a reverse-phase C18 column, using a mobile phase containing phosphate buffer (pH 3.5): acetonitrile at 1.5 mL min −1 �ow rate, detection wavelength 256 nm, column oven temperature 25 ∘ C, and injection volume 10 L. Linearity was established in the range of 20-300 g mL −1 , 24.5-367.5 g mL −1 and 60-900 g mL −1 for FTC, TDF, and EFV, respectively. e method was successfully applied for quantifying the drugs in marketed dosage forms and on stability samples.
A novel, sensitive and precise UHPLC method has been developed and validated for the simultaneous... more A novel, sensitive and precise UHPLC method has been developed and validated for the simultaneous determination of the all the active components of a Polypill viz Zycad, i.e., Aspirin (ASP) Atorvastatin (ATV), Ramipril (RMP) and Metoprolol (MTP) in Zycad tablet dosage form in the presence of degradation products. Forced degradation of individual as well as combination of all the drug substances components of Polypill was conducted in accordance with ICH guidelines. Acidic, basic, neutral, and oxidative hydrolysis, thermal stress, and photolytic degradation were used to assess the stability-indicating power of the method. Use of 100 × 2.1 mm, 1.7 µm stationary phases with simple mobile phase combination buffer consisting of 0.1% Perchloric acid (adjusted to pH 2.5) and Acetonitrile, delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 215 nm with a flow rate of 0.6 mL·min -1 . The method was optimized using samples generated by forced degradation studies. The method was validated for linearity, accuracy (recovery), precision, Specificity and robustness. The method was linear in the range of 37.5 to 150.0 µg·mL -1 for ASP, 5.0 to 20.0 µg·mL -1 for ATV and 2.5 to 10.0 µg·mL -1 for RMP and 25.0 to 100.0 µg·mL -1 for MTP.
Polypill is a fixed-dose combination (FDC) containing three or more drugs in a single pill with t... more Polypill is a fixed-dose combination (FDC) containing three or more drugs in a single pill with the intention of reducing the number of tablets or capsules that need to be taken. Developing a single analytical method for the estimation of individual drugs in a Polypill is very challenging, due to the formation of drug-drug and drug-excipients interaction impurities. Here an attempt was made to develop a new, sensitive, single stability-indicating HPLC method for the simultaneous quantitative determination of Aspirin (ASP) Atorvastatin (ATV), Atenolol (ATL) and Losartan potassium (LST) in a polypill form in the presence of degradation products. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination of buffer and Acetonitrile. Buffer consists of 0.1% Orthophosphoric acid (pH 2.9), delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 230 nm with a flow rate of 1.0 mL/min. The retention times of Atenolol, Aspirin, Losartan potassium, and Atorvastatin were 3.3, 7.6, 10.7 and 12.9 min respectively. The combination drug product are exposed to thermal, acid/base hydrolytic, humidity and oxidative stress conditions, and the stressed samples were analyzed by proposed method. The method was validated with respect to linearity; the method was linear in the range of 37.5 to 150.0 µg/mL for ASP, 5.0 to 20.0 µg/mL for ATV and 25.0 to 100.0 µg/mL for ATL and LST. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. The validated method was successfully applied to the analysis of Starpill tablets constituting all the four drugs; the percentage recoveries obtained were 99.60% for ASP, 99.30% for ATV, 99.41% for ATL and 99.62% for LST.