Development and Validation of a Dissolution Method for Pioglitazone Tablets

Lercanidipine hydrochloride (HCl) is L-type calcium channel blocker widely used in the management of hypertension. According to the BCS classification system, it is classified under BCS class II drugs, showing low solubility and high permeability. The dissolution profile and thus the in vivo performance of this class of drugs widely depend on their solubility and hence their behaviour in dissolution medium. Lercanidipine HCl is not official in any pharmacopeia, so no official dissolution method is available. The present work is mainly focussed on development and validation of a dissolution test that can be used as a quality control test for lercanidipine HCl tablets and formulations. Saturation solubility and sink conditions that can be achieved in different media suggested that 0.1 N HCl, acetate buffer pH 4.5, and phosphate buffer pH 6.8 can be used as a dissolution medium. Dissolution tests of lercanidipine HCl tablets were carried out in these different media at different rotation speeds using a USP type II (paddle) apparatus. The most suitable dissolution conditions were 0.1 N HCl pH 1.2 (900 mL at 37 ± 0.5 °C) as a dissolution medium and a paddle apparatus at 100 rpm for 60 min. The analysis of released lercanidipine HCl was done by ultraviolet spectrophotometry. The developed method was validated according to ICH guidelines. This method showed linearity with an r 2 value of 0.999 within the concentration range of 2-20 µg/mL. The method was found to be accurate with recoveries ranging from 98.50% to 103.72%. The interday and intraday precision was below RSD 2%. The developed method can effectively be used for quality control evaluation of lercanidipine HCl tablets.

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“…After selecting the optimum dissolution test conditions, the dissolution method was validated (26,27).…”

Section: Validation Of Dissolution Methodsmentioning

confidence: 99%

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Shaikh¹,

Patel²,

Patel³

et al. 2018

Dissolution Technol.

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“…doses of granules from same batch and samples were analyzed according to the test method and aliquots were taken at the end of 60 minutes [15].…”

Section: Methods Precision/repeatability It Was Performed Onmentioning

confidence: 99%

Development and Validation of a Discriminating In Vitro Dissolution Method for Oral Formulations Containing Satranidazole

Pawar

Joshi

2014

International Journal of Spectroscopy

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The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to the pharmaceutical industry. Satranidazole (BCS Class II drug) is a new nitroimidazole derivative with potent antiamoebic action. There is no official dissolution medium available in the literature. In the present study, parameters such as saturation solubility in different pH medium, dissolution behavior of formulations, influence of sink conditions, stability, and discriminatory effect of dissolution testing were studied for the selection of a proper dissolution medium. Results of solubility data revealed that solubility of Satranidazole decreases with an increase in pH. Satranidazole showed better sink condition in 0.1 N HCl as compared to other media. The drug and marketed formulations were stable in the dissolution media used. An agitation speed of 75 rpm showed a more discriminating drug release profile than 50 rpm. Using optimized dissolution parameters (paddle at 75 rpm, 900 mL 0.1 N HCl) greater than 80% of the label amount is released over 60 minutes. UV-spectroscopic method used was validated for the specificity, linearity, precision, robustness, and solution stability. The method was successfully applied to granular formulations and also to marketed tablets containing 300 mg Satranidazole.

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“…It is centrally acting Antitussive. [5][6][7][8] Noscapine inhibit bradykinin as the mode by which it functions. Noscapine's effect in treating strokes has been attributed to its Bradykinin suppressive effect and its anti-cancer effect has been primarily attributed to its Microtubuleinterfering effect.…”

Section: • Selection Of Other Parametersmentioning

confidence: 99%

Dissolution Method Development and Validation for Estimation of Noscapine Tablets

Vyas¹,

Solanaki²,

Daxini³

et al. 2020

J. Drug Delivery Ther.

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A dissolution method was developed and UV spectrophotometry was developed for the evaluation of the dissolution of tablets containing 15 mg Noscapine .The dissolution medium 0.1 N HCl was found suitable to ensure sink conditions. USP Apparatus 2, 900 mL dissolution medium 45 minutes and 100 RPM were fixed. Dissolution profiles were generated at 10, 15, 20, 30; 45 min. Dissolution samples were analyzed with UV spectrophotometer at 213 nm. The UV method for determination of tablet was developed and validated. The method presented linearity (R2 = 0.999) in the concentration range of 1–9 μg/mL. The recoveries were good, ranging from 97.18% to 101.45%. The intraday and Interday precision results were 0.54% and 0.78% RSD, respectively. The developed dissolution test is adequate for its purpose and can be applied for the quality control of tablets. Keywords: Dissolution test; Noscapine; Tablets; UV Spectrophotometry method

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Development and Validation of a Dissolution Method for Pioglitazone Tablets

Cited by 13 publications

References 14 publications

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Development and Validation of a Discriminating In Vitro Dissolution Method for Oral Formulations Containing Satranidazole

Dissolution Method Development and Validation for Estimation of Noscapine Tablets

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