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Stability-indicating HPTLC method for quantitation of quetiapine fumarate in the pharmaceutical dosage form

Dhaneshwar S. R., Patre N. G., Mahadik M. V.

Acta Chromatographica

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2009

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Vol. 21, no. 1

83-93

EN

A sensitive, selective, precise, and stability-indicating HPTLC method for quantitative analysis of quetiapine fumarate both as the bulk drug and in formulations has been established and validated. The stationary phase was silica gel and the mobile phase toluene-methanol 8:2 (v/v). This system gave compact bands for quetiapine fumarate ( R F 0.37 š 0.02). Densitometric analysis of quetiapine fumarate was performed in absorbance mode at 254 nm. There was no chromatographic interference from tablet excipients. Quetiapine fumarate was subjected to acid and alkaline hydrolysis, oxidation, and photodegradation. The drug is susceptible to all these treatments. The degradation products were well resolved from the pure drug with substantially different R F values. The method was validated for linearity, precision, accuracy, selectivity, and specificity in accordance with ICH guidelines. Because the method can effectively separate the drug from its degradation products, it can be used as a stability indicating method.

2

Application of a stability-indicating HPTLC method for quantitative analysis of amtolmetin guacil in a pharmaceutical dosage form

Bhusari V. K., Mahadik M. V., Dhaneshwar S. R.

Acta Chromatographica

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2009

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Vol. 21, no. 2

299--317

EN

A sensitive, selective, precise, and stability-indicating HPTLC method has been established for analysis of amtolmetin guacil both as the bulk drug and in a formulation. Aluminum foil-backed silica gel 60F 254 plates were used with toluene-ethyl acetate 4:6 ( υ/υ ) as mobile phase, and densitometric analysis was performed in absorbance mode at 320 nm. The method was validated for linearity, precision, accuracy, selectivity, and specificity in accordance with ICH guidelines. Amtolmetin guacil was subjected to acidic and alkaline hydrolysis, oxidation, dry heat treatment, and photo-degradation. The method was used to study the kinetics of degradation of amtolmetin guacil by acid and alkali.

3

Development and validation of a method for simultaneous densitometric analysis of simvastatin and ezetimibe as the bulk drugs and in the tablet dosage form

Dhaneshwar S. S., Deshpande P., Patil M., Vadnerkar G., Dhaneshwar S. R.

Acta Chromatographica

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2008

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Vol. 20, no. 1

71-79

EN

Simvastatin is a selective HMG-CoA reductase inhibitor and ezetimibe has lipid-lowering activity. Both are potential anti-lipidemic agents used in combination to reduce the amount of cholesterol and triglycerides in systemic circulation. This paper describes a simple, precise, and accurate HPTLC method for simultaneous estimation of the compounds as the bulk drugs and in the tablet dosage form. Chromatographic separation was performed on aluminium-backed silica gel 60 F254 plates with 8:2 (v/v) toluene- 2-propanol as mobile phase. The separated spots were densitometrically evaluated at 240 nm. The drugs were satisfactorily resolved with RF values 0.48 š 0.01 and 0.53 š 0.01 for simvastatin and ezetimibe, respectively. The accuracy and reliability of the method were assessed by determination of validation data for linearity (0.4-2.0 µg per spot for both simvastatin and ezetimibe), precision (intra-day RSD 0.51-1.04%, inter-day RSD 0.34-1.11% for simvastatin; intra-day RSD 0.47-0.61%, inter-day RSD 0.31-0.61% for ezetimibe), accuracy (98.50 š 0.23 for simvastatin and 98.99 š 0.38 for ezetimibe), and specificity, in accordance with ICH guidelines. The proposed method can be used for analysis of ten or more formulations on a single plate and is a rapid and cost-effective quality-control tool for routine simultaneous analysis of simvastatin and ezetimibe as the bulk drugs and in tablet formulations.

4

High-performance thin-layer chromatographic method for determination of erdosteine in pharmaceutical dosage forms

Mhaske D. V., Dhaneshwar S. R.

Acta Chromatographica

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2007

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No. 19

170-184

EN

A sensitive, selective, precise, and stability-indicating method for quantitative analysis of erdosteine, in the presence of its degradation products, both as the bulk drug and in a formulation has been established and validated. High-performance thin layer chromatography (HPTLC) on aluminium-backed silica gel 60 F254 plates with toluene–methanol–acetone–ammonia 3.5:3.5:2.5:0.05 (v/v) as mobile phase was followed by densitometric measurement at 254 nm. This system was found to give compact bands for erdosteine (RF 0.45 ± 0.02). The method was validated in accordance with ICH guidelines There was no chromatographic interference from capsule excipients. Erdosteine was subjected to acid and alkaline hydrolysis, oxidation, dry heat, wet heat, and UV degradation. The drug is degraded by acid and alkaline hydrolysis, oxidation, and UV irradiation. The drug was found to be stable under wet and dry heat conditions. Because the method could effectively separate the drug from its degradation products it can be regarded as stability-indicating.

5

Development and validation of a method for simultaneous densitometric estimation of atorvastatin calcium and ezetimibe as the bulk drug and in tablet dosage forms

Dhaneshwar S. S., Dhaneshwar S. R., Deshpande P., Patil M.

Acta Chromatographica

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2007

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No. 19

141-148

EN

Atorvastatin calcium is a selective HMG-CoA reductase inhibitor and ezetimibe has lipid-lowering activity. Both are potential anti-lipidaemic agents used in combination to reduce the amount of cholesterol and triglycerides in systemic circulation. This paper describes a simple, precise, and accurate HPTLC method for simultaneous quantification of these compounds as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminium plates precoated with silica gel 60 F254, with toluene–methanol 8:2 (v/v) as mobile phase. Densitometric evaluation of the separated zones was performed at 240 nm. The two drugs were satisfactorily resolved with RF values 0.23 ± 0.01 and 0.39 ± 0.01 for atorvastatin calcium and ezetimibe, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (0.4–2.4 µg/zone for both atorvastatin calcium and ezetimibe), precision (intra-day RSD 1.16–1.25% and inter-day RSD 1.16–1.44% for atorvastatin calcium, and intra-day RSD 0.47–0.63% and inter-day RSD 0.47–0.88% for ezetimibe), accuracy (98.51 ± 0.23% for atorvastatin calcium and 99.01 ± 0.15% for ezetimibe), and specificity, in accordance with ICH guidelines. The method can be used for analysis of ten or more formulations on a single plate and is a rapid and cost-effective quality-control tool for routine simultaneous analysis of atorvastatin calcium and ezetimibe as the bulk drug and in tablet formulations.