Comparison of the dissolution of metaxalone tablets (Skelaxin) usingUSP apparatus 2 and 3

Cacace, Janice; Reilly, Eugene E.; Amann, Anton

doi:10.1007/bf02830574

Cited by 6 publications

(2 citation statements)

References 4 publications

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“…Some of the reported methods for DIC include UV-spectroscopic methods [3–6], RP-HPLC methods [7–10] and LC-MS method [11]. For MET the reported methods are UV-Spectroscopic method [12], RP-HPLC method [13, 14] and LC-MS method [15]. Only one RP-HPLC method has been reported so far for simultaneous estimation of both the drugs [16], but the reported method is not stability-indicating in nature.…”

Section: Introductionmentioning

confidence: 99%

New Stability-Indicating RP-HPLC Method for Determination of Diclofenac Potassium and Metaxalone from Their Combined Dosage Form

Panda

Patanaik²,

Kumar³

2012

Sci. Pharm.

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A simple, precise and accurate isocratic RP-HPLC stability-indicating assay method has been developed to determine diclofenac potassium and metaxalone in their combined dosage forms. Isocratic separation was achieved on a Hibar-C18, Lichrosphere-100® (250 mm × 4.6 mm i.d., particle size 5 μm) column at room temperature in isocratic mode, the mobile phase consists of methanol: water (80:20, v/v) at a flow rate of 1.0 ml/min, the injection volume was 20 μl and UV detection was carried out at 280nm. The drug was subjected to acid and alkali hydrolysis, oxidation, photolysis and heat as stress conditions. The method was validated for specificity, linearity, precision, accuracy, robustness and system suitability. The method was linear in the drug concentration range of 2.5–30 μg/ml and 20–240 μg/ml for diclofenac potassium and metaxalone, respectively. The precision (RSD) of six samples was 0.83 and 0.93% for repeatability, and the intermediate precision (RSD) among six-sample preparation was 1.63 and 0.49% for diclofenac potassium and metaxalone, respectively. The mean recoveries were between 100.99–102.58% and 99.97–100.01% for diclofenac potassium and metaxalone, respectively. The proposed method can be used successfully for routine analysis of the drug in bulk and combined pharmaceutical dosage forms.

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Section: Introductionmentioning

confidence: 99%

New Stability-Indicating RP-HPLC Method for Determination of Diclofenac Potassium and Metaxalone from Their Combined Dosage Form

Panda

Patanaik²,

Kumar³

2012

Sci. Pharm.

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“…Very few methods have appeared in the literature for the assay determination of META in bulk and pharmaceutical dosage forms by high-performance liquid chromatography (HPLC) [10–12]. Narasimha et al.…”

Section: Introductionmentioning

confidence: 99%

Development of a Stability Indicating RP-UPLC Method for Rapid Determination of Metaxalone and its Degradation Products in Solid Oral Dosage Form

Trivedi

2012

Sci. Pharm.

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A simple, sensitive and reproducible reversed phase ultra performance liquid chromatography (RP-UPLC) coupled with a photodiode array detector method was developed for the quantitative determination of metaxalone (META) in pharmaceutical dosage forms. The method is applicable to the quantification of related substances and assay of drug product. Chromatographic separation was achieved on an Acquity® HSS-T3 (100 mm x 2.1 mm, 1.7 μm) column. The optimized isocratic mobile phase consists of a mixture of water, methanol, acetonitrile and triethylamine in the ratio of 50:25:25:0.1 % v/v (pH adjusted to 6.3 with orthophosphoric acid). The eluted compounds were monitored at 230 nm for META assay and 205 nm for related substances, the flow rate was 0.3 mL/min, and the column oven temperature was maintained at 45°C. The developed method separated META from its two known and two unknown impurities within 6.0 min. Metaxalone was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Metaxalone was found to degrade significantly in base stress condition, degrade slightly in oxidative stress condition and remain stable in acid, hydrolytic, thermal and photolytic degradation conditions. All impurities were well resolved from each other and from the main peak, showing the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines.

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Dissolution Testing:In vitroCharacterization of Oral Controlled Release Dosage Forms

Guo¹

2010

Oral Controlled Release Formulation Design and Drug Delivery

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Comparison of the dissolution of metaxalone tablets (Skelaxin) usingUSP apparatus 2 and 3

Cited by 6 publications

References 4 publications

New Stability-Indicating RP-HPLC Method for Determination of Diclofenac Potassium and Metaxalone from Their Combined Dosage Form

New Stability-Indicating RP-HPLC Method for Determination of Diclofenac Potassium and Metaxalone from Their Combined Dosage Form

Development of a Stability Indicating RP-UPLC Method for Rapid Determination of Metaxalone and its Degradation Products in Solid Oral Dosage Form

Dissolution Testing:In vitroCharacterization of Oral Controlled Release Dosage Forms

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