Stability indicating HPTLC method for determination of terbutaline Sulfate in bulk and from Submicronized dry Powder inhalers

Faiyazuddin, Md.; Ahmad, Sayeed; Iqbal, Zeenat; Talegaonkar, Sushama; Ahmad, Farhan Jalees; Bhatnagar, Aseem; Khar, Roop K.

doi:10.2116/analsci.26.467

Cited by 19 publications

(8 citation statements)

References 32 publications

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“…[13] In brief, samples were spotted in the form of bands of width 6 mm with a Camag microlitre syringe on precoated silica gel aluminum Plate 60 F–254 (20 × 10 cm with 250 μm thickness; E. Merck, Darmstadt, Germany, supplied by Anchrom Technologists, Mumbai, India) using a Camag Linomat IV (Muttenz, Switzerland). The plates were prewashed by methanol and activated at 60°C for 5 min prior to chromatography.…”

Section: Methodsmentioning

confidence: 99%

Stability-indicating assay of repaglinide in bulk and optimized nanoemulsion by validated high performance thin layer chromatography technique

2013

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A sensitive, selective, precise and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for analysis of repaglinide both as a bulk drug and in nanoemulsion formulation was developed and validated. The method employed TLC aluminum plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of chloroform/methanol/ammonia/glacial acetic acid (7.5:1.5:0.9:0.1, v/v/v/v). This system was found to give compact spots for repaglinide (Rf value of 0.38 ± 0.02). Repaglinide was subjected to acid and alkali hydrolysis, oxidation, photodegradation and dry heat treatment. Also, the degraded products were well separated from the pure drug. Densitometric analysis of repaglinide was carried out in the absorbance mode at 240 nm. The linear regression data for the calibration plots showed good linear relationship with r2= 0.998 ± 0.032 in the concentration range of 50-800 ng. The method was validated for precision, accuracy as recovery, robustness and specificity. The limits of detection and quantitation were 0.023 and 0.069 ng per spot, respectively. The drug undergoes degradation under acidic and basic conditions, oxidation and dry heat treatment. All the peaks of the degraded product were resolved from the standard drug with significantly different Rf values. Statistical analysis proves that the method is reproducible and selective for the estimation of the said drug. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one. Moreover, the proposed HPTLC method was utilized to investigate the degradation kinetics in 1M NaOH.

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Section: Methodsmentioning

confidence: 99%

Stability-indicating assay of repaglinide in bulk and optimized nanoemulsion by validated high performance thin layer chromatography technique

2013

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“…There are some other literature review showed the estimation of these drug in combination with another drug formulation by different analytical methods such as, spectrophotometric simultaneous analysis of Ambroxol Hydrochloride, Guaifenesin and Terbutaline Sulphate in liquid dosage form such as syrup 25 , RP-HPLC and stability indicating HPLC methods for simultaneous determination of Terbutaline alone and with combinations [26][27][28][29] , simultaneous determination of Terbutaline Sulphate with other drugs in tablet formulation by UV Spectrophotometry 30 , stability indicating HPTLC method for determination of Terbutaline Sulphate in bulk and from submicronised dry powder inhalers 31 . Thus, this present study report deals with the simultaneous estimation of Doxofylline and Terbutaline Sulphate by HPLC in bulk drug and tablet dosage form.…”

Section: Fig 2: Structure Of Doxofyllinementioning

confidence: 99%

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2019

IJPSR

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A new simple, rapid, and sensitive reversed-phase liquid chromatographic method was developed for the estimation of doxofylline and terbutaline in the tablet dosage form. The chromatographic separation was achieved on ODS C 18 column (150 × 4.6 mm, 5 µm) at ambient temperature and effluent monitored at 257 nm. The mobile phase consists of ammonium acetate buffer (pH adjusted to 3 with o-phosphoric acid) and acetonitrile in the ratio of 50:50 v/v. The flow rate was maintained at 1 ml/min. The method was validated concerning linearity, precision, accuracy, ruggedness, limit of detection, limit of quantification and robustness. The assay methods were found to be linear from 16-96 µg/ml for doxofylline and 0.2-1.2 µg/ml for terbutaline. All validation parameters were within the acceptable range. The mean recovery was 99.35 and 99.25 for doxofylline and terbutaline respectively. The % RSD value was found to be less than 2. The limit of detection and limit of quantification for doxofylline and terbutaline were found to be 0.06 μg/ml and 0.024 μg/ml and 0.21μg/ml and 0.079 μg/ml respectively. The result of the study showed that the proposed RP-HPLC method for the simultaneous estimation of doxofylline and terbutaline in the tablet dosage form is simple, accurate, sensitive, precise, specific and rapid which is useful for routine analysis of doxofylline and terbutaline in its formulations. QUICK RESPONSE CODE

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“…A validated HPLC method for the determination of TB and its possible degradation products has been reported in literature [16], utilizing Hypersil 100 C 18 , 150 4.6 mm (5 m) column, found inadequate sensitivity of the method due to high limit of quantitation (LOQ; 0.11 g mL -1 ) and limit of detection (LOD; 0.37 g mL -1 ) values. In our previous study, a stability-indicating high performancethin layer chromatography (HPTLC) has been developed and validated for the direct estimation of TB and its potential degradants in bulk and submicronized dry powder inhalers *Address correspondence to this author at the Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi-110062, India; Tel: +91-7668963486; E-mail: md.faiyazuddin2008@gmail.com [17]. The low value of LOQ (28.35 ng spot -1 ) and LOD (9.41 ng spot -1 ) indicated adequate assay sensitivity of our reported method.…”

Section: Terbutaline (Tb) An Amphiphilicmentioning

confidence: 99%

Development and Validation of UHPLC/ESI-Q-TOF-MS Method for Terbutaline Estimations in Experimental Rodents: Stability Effects and Plasma Pharmacokinetics

Faiyazuddin¹,

Ahmad

Iqbal³

et al. 2012

CPA

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An ultra high performance liquid chromatography-electrospray ionization-tandem mass spectrometric method (UHPLC/ESI-Q-TOF-MS) for the analysis of terbutaline (TB) in Wistar rat plasma has been developed and validated. The chromatographic separation was achieved on a Waters ACQUITY UPLC TM BEH C18 (100.0 mm 2.1 mm; 1.7 m) column using isocratic mobile phase, consisting of 2 mM ammonium acetate and acetonitrile (90: 10; v/v), at a flow rate of 0.25 mL min-1. The transitions occurred at m/z 226.19 152.12 for TB, and m/z 260.34 183.11 for the internal standard. The recovery of the analytes from Wistar rat plasma was optimized using liquid-liquid extraction technique (LLE) in ethyl acetate. The total run time was 3.0 min and the elution of TB occurred at 1.85±0.05 min. The linear dynamic range was established over the concentration range 1-1000 ng mL-1 (r 2 ; 0.9938±0.0005) for TB. The intra-assay and inter-assay accuracy in terms of % CV was in between 1.8-3.5. The lower limit of quantitation (LLOQ) for TB was 1.0 ng mL-1. Analytes were stable under various conditions (in autosampler, during freeze-thaw, at room temperature, and under deepfreeze conditions). The developed method was successfully applied for pharmacokinetic profiling in rodents.

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Stability indicating HPTLC method for determination of terbutaline Sulfate in bulk and from Submicronized dry Powder inhalers

Cited by 19 publications

References 32 publications

Stability-indicating assay of repaglinide in bulk and optimized nanoemulsion by validated high performance thin layer chromatography technique

Stability-indicating assay of repaglinide in bulk and optimized nanoemulsion by validated high performance thin layer chromatography technique

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Development and Validation of UHPLC/ESI-Q-TOF-MS Method for Terbutaline Estimations in Experimental Rodents: Stability Effects and Plasma Pharmacokinetics

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