Validated analytical methods of repaglinide in bulk and tablet formulations

Rajput, SJ; Chaudhary, BG

doi:10.4103/0250-474x.22987

Cited by 7 publications

(5 citation statements)

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“…Five tablets were selected at random and were powdered in a mortar; and amount of powder equivalent to single dose was dissolved in methanol [21] by sonication for 15 min and filtered through Whatmann filter (0.45 μm) paper. The drug content was analyzed spectrophotometrically at 281 nm using a UV spectrophotometer.…”

Section: Content Uniformitymentioning

confidence: 99%

Formulation and evaluation of bioadhesive buccal drug delivery of repaglinide tablets

Patel¹,

Patel²,

Shah³

2012

Asian J Pharm

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T he purpose of this research was to formulate and evaluate bioadhesive buccal tablets of repaglinide using HPMC K15M as a sustained release polymer, chitosan as a bioadhesive polymer and ethyl cellulose as an impermeable backing layer. The tablets were evaluated for weight variation, thickness, hardness, friability, surface pH, mucoadhesive strength, swelling index, in vitro drug release, ex vivo mucoadhesion time and ex vivo drug permeation. A 3 2 full factorial design was used in present study for optimization. Tablets containing HPMC K15M and chitosan in the ratio of 1:1 and lactose as a filler (F2) had the maximum percentage of in vitro drug release. The swelling index, friability and in vitro drug release was affected by type of filler as dicalcium phosphate (DCP) had good binding ability compared to lactose. The surface pH of all tablets was found to be satisfactory (between 6.26 and 7.01), close to neutral pH; hence buccal cavity irritation should not occur with these tablets. F2 batch was considered optimum based on good bioadhesive strength (17.83±0.51 gm) and maximum similarity factor (64.43). The drug release from optimum batch followed zero order kinetics with non-Fickian diffusion. Drugexcipients compatibility study showed no interaction between drug and excipients. Stability study of optimized formulation showed that tablets were stable at accelerated environment condition. Thus, buccal adhesive tablet of repaglinide could be an alternative route to bypass hepatic first pass metabolism and to improve bioavailability of repaglinide.

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Section: Content Uniformitymentioning

confidence: 99%

Formulation and evaluation of bioadhesive buccal drug delivery of repaglinide tablets

Patel¹,

Patel²,

Shah³

2012

Asian J Pharm

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“…UV and Mass Spectroscopy; and Chromatographic methods viz. High Performance Liquid Chromatography (HPLC); High Performance Thin Layer Chromatography (HPTLC) has been reported individually 6 -7 and also in different class of combination like Repaglinide alone [8][9][10][11][12] , Sitagliptin alone [13][14] , Repaglinide and Metformin 15 -18 , Sitagliptin and Metformin [19][20][21][22][23][24] and many more. Since no method has been develop and validated for simultaneous estimation of Repaglinide and Sitagliptin phosphate in combination.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Stability Indicating RP-HPLC and UV Method for Simultaneous Quantitation of Repaglinide and Sitagliptin Phosphate in Combination

Shaikh¹,

Jat²,

Bhangale³

2020

AJPTR

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The present work describes Stability indicating RP-HPLC and Simultaneous equation UV spectrophotometric method for the quantitative determination of Repaglinide and Sitagliptin phosphate. The parameters Specificity, linearity, accuracy, precision, detection limit, quantitation limit, Robustness and system suitability tests were studied and their results were complied to ICH guideline Q2 (R1). Chromatography was carried out by reverse phase technique on an RP-18 with mobile phase composed of Acetonitrile: Phosphate buffer (65:35; % v/v) adjusted to pH 3.5 with 10% orthophosphoric acid) with flow rate 1 ml/min. Both drugs were eluted, isocratically using detection wavelength 228 nm. Simultaneous equation UV spectrophotometric method was performed and two wavelengths 240 nm (λmax of Repaglinide) and 267 nm (λmax of Sitagliptin phosphate) were selected for the formation of simultaneous equation. The A (1%, 1cm) was determined at both the wavelengths selected for each drug. A set of two simultaneous equations were formed as Cx and Cy. Methanol used as Solvent (diluent) for UV method. For proposed methods, the linearity for both methods were obtained in the concentration range of 0.5-2.5 μg/ml for Repaglinide and 50-250 μg/ml for Sitagliptin phosphate. Statistical analysis by student's t-test showed no significance difference between the results obtained by these two methods. The suitability of method for the quantitative determination of Repaglinide and Sitagliptin phosphate was proved by validation. The proposed methods and its results had been successfully applied and validated statistically to the simultaneous estimation of Repaglinide and Sitagliptin phosphate in their combination for quality analysis.

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“…An HPLC method for the determination of RPG was described in the United Sates Pharmacopoeia (USP) [27]. Electrochemical, spectrophotometric and chromatographic methods have also been reported for the determination of RPG [5,7,11,19,20]. RGZ has been determined by first-order UV spectroscopy and chromatography [6,10,12].…”

Section: Introductionmentioning

confidence: 99%

Fourier transform infrared spectroscopy for in-process inspection, counterfeit detection and quality control of anti-diabetic drugs

2011

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Abstract. The purpose of this study is to develop simple and cost-effective Fourier transform infrared (FT-IR) methods for quality control evaluation of repaglinide (RPG), rosiglitazone maleate (RGZ), pioglitazone hydrochloride (PGZ) and metformin hydrochloride (MET) and assess their use for in-process quality control and detection of counterfeit medicine. The conventional KBr disc sampling technique used in FT-IR does not result in constant path-length thus impeding the use of this sensitive and simple technique for quantification of drugs. In this study, FT-IR quantitative assays were developed using a constant KBr disc pathlength to quantify drugs in bulk and tablets. Method validation was done according to the International Conference on Harmonization (ICH) guidelines and recovery studies were performed by applying standard addition technique. Samples representing pitfalls at different tablet manufacturing stages and counterfeit medicines were prepared and tested by FT-IR. The developed methods achieved ICH validation parameters. Statistical comparison of the results with reference or reported methods showed no significant difference with respect to method accuracy and precision. The methods were applicable to tablet dosage form with average recovery ranging between 99 and 102%. The developed methods are capable of detecting impurities that result from in-process manufacturing problems and counterfeit products and are inclusive for in-process and end product testing.

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Validated analytical methods of repaglinide in bulk and tablet formulations

Cited by 7 publications

References 0 publications

Formulation and evaluation of bioadhesive buccal drug delivery of repaglinide tablets

Formulation and evaluation of bioadhesive buccal drug delivery of repaglinide tablets

Development and Validation of Stability Indicating RP-HPLC and UV Method for Simultaneous Quantitation of Repaglinide and Sitagliptin Phosphate in Combination

Fourier transform infrared spectroscopy for in-process inspection, counterfeit detection and quality control of anti-diabetic drugs

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