High-Performance Liquid Chromatographic Analysis of Isoniazid and Its Dosage Forms

Abdou, Hamed M.

doi:10.1002/jps.2600660427

Cited by 16 publications

(7 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although AcINH and INA are chemically inert, INH has the propensity of reacting with aldehydes and ketones. Providing sugars such as lactose are avoided (Bailey & Abdou, 1977), it should be possible to prepare suitable isoniazid-tagged formulations of most drugs; indeed commercial formulations of isoniazid combined with drugs such as thiacetazone, ethionamide, prothionamide and rifampicin have been widely used in the treatment of tuberculosis and have displayed the same excellent keeping properties characteristic of the separately formulated drugs. In situations where sugar coated tablets were required, the INH marker might be incorporated into either an outer film or 'spot'.…”

Section: Discussionmentioning

confidence: 99%

An evaluation of the potential use of isoniazid, acetylisoniazid and isonicotinic acid for monitoring the self‐administration of drugs.

Ellard¹,

Jenner²,

Downs³

1980

Brit J Clinical Pharma

View full text Add to dashboard Cite

1. The possibility of using minute doses of the antituberculosis drug isoniazid (INH) or of its metabolites acetylisoniazid (AcINH) or isonicotinic acid (INA) as innocuous markers for monitoring patient compliance has been investigated. 2. The ingestion of these colourless and tasteless compounds can readily be demonstrated using a sensitive and specific colorimetric method for detecting INA and its metabolite isonicotinylglycine (INAG) in the urine that is rapid and simple to perform. 3. Studies on the kinetics of the urinary elimination of INA and INAG after the ingestion of 6 mg doses of either INH, AcINH or INA by small groups of volunteers indicated the potential suitability of INH or AcINH for monitoring daily or twice-daily self-medication and the appropriateness of INA as a marker for investigating the compliance of drugs prescribed for thrice-daily ingestion. 4. More extensive studies showed that over 99% of the urine samples collected within 18h of dosage with 6 mg INH would give positive results when tested for the presence of INA and INAG, and that doses of 2-6 mg INH could readily by incorporated into capsules or tablets and used as markers for monitoring the ingestion of the antituberculosis or antileprosy drugs dapsone, thiacetazone, ethionamide or prothionamide, or the antihypertensive oxprenolol. Such doses are less than a fiftieth of the normal therapeutic INH dose used in the treatment of tuberculosis. 5. Evidence is presented that INH, AcINH and INA possess most of the characteristics that one would hope to find in a marker for monitoring compliance including very limited inter-individual variability in the rates at which they are converted to the compounds being detected in the urine.

show abstract

Section: Discussionmentioning

confidence: 99%

An evaluation of the potential use of isoniazid, acetylisoniazid and isonicotinic acid for monitoring the self‐administration of drugs.

Ellard¹,

Jenner²,

Downs³

1980

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…After the solution was concentrated under vacuum (Savant Speed Vac ® -PD121P concentrator), 30 ml of methanol were added to the crude product and the mixture was refrigerated overnight at 4 • C. The product was then filtered and dried. The TLC analysis of the hydrazone, according to the method reported by Bailey and Abdou [17], indicated an apparent purity of 99%.…”

Section: Solutionsmentioning

confidence: 90%

Quantification of isonicotinoyl lactosyl hydrazone in oral pharmaceutical dosage forms

Córdoba-Díaz

Elorza

2009

Spectroscopy

View full text Add to dashboard Cite

Isoniazid, one of the most important drugs for the chempublisher-idapy of tuberculosis, can react with some widely used pharmaceutical excipients, like lactose, leading to the formation of hydrazones. This interaction can dramatically modify the oral bioavailability of the drug, what could lead to a failure of the treatment. Some analytical methods, including techniques like HPLC, can be used to quantify this type of products, but all of them are tedious and time-consuming. In this sense, the aim of the present work is to develop a sensitive, rapid and cheap alternative to publisher-id published methods. For this reason, two spectrophotometric methods were developed and validated. In the first one, isoniazid and its lactosyl-hydrazone were measured together. The second one involved a reaction between not bound to lactose isoniazid and 2,3-dichloro-1,4-naphthoquinone. Lactosyl-hydrazone is quantified by comparison of the results obtained from both methods. The linearity is confirmed to be within a range of 1.5–30.0 μg/ml of total isoniazid and 0.5–30.0 μg/ml of “free” isoniazid. Limits of quantification of 1.2 μg/ml and 0.3 μg/ml were obtained for bound and free isoniazid respectively. These results indicated that the here described methods are at least, as sensitive and accurate as the vast majority of the previously published chromatographic methods. This methodology shows a good repeatability (RSD below 2.0%) as well as good accuracy (average recoveries of 100.83% and 99.96% for total and free isoniazid respectively). The results obtained from the assay of isoniazid tablets demonstrated that the proposed method constitutes a clear alternative to chromatographic methods and also to the official titration method. It would be of interest for the routine quality control of oral dosage forms containing isoniazid and lactose and for stability studies.

show abstract

“…2 Isoniazid is susceptible to hydrolysis and oxidation and interacts with excipients, particularly reducing sugars, to form hydrazones. 2,3 The hydrazone formed by the reaction of isoniazid with lactose (pH 1.0-6.0) is 1isonicotinoyl-2-lactosylhydrazine. 2,3 There are also reported incompatibilities between lactose and other drugs containing a primary or secondary amine functional group, as is the case with isoniazid.…”

Section: Introductionmentioning

confidence: 99%

“…2,3 The hydrazone formed by the reaction of isoniazid with lactose (pH 1.0-6.0) is 1isonicotinoyl-2-lactosylhydrazine. 2,3 There are also reported incompatibilities between lactose and other drugs containing a primary or secondary amine functional group, as is the case with isoniazid. 4 Differential scanning calorimetry is a powerful tool in preformulation and stability studies for the rapid evaluation of the compatibility of active ingredients and excipients used in solid dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Extemporaneous Isoniazid Mixture: Stability Implications

Haywood

Mangan

Grant

et al. 2005

Pharmacy Practice and Res

View full text Add to dashboard Cite

Background: Isoniazid mixtures are compounded in Australia using commercially available isoniazid tablets. Aim: To determine the stability of isoniazid 10 mg/mL mixture compounded from commercially available isoniazid tablets. Method: The stability of the compounded isoniazid mixture stored at a range of temperatures (4-60 °C) was assessed with high performance liquid chromatography. Differential scanning calorimetry was used to investigate the compatibility of isoniazid with the excipient, lactose. Results: The compounded isoniazid mixture exhibited significant degradation (≥ ≥ ≥ ≥ ≥ 10% after 3 days at 4 and 25 ºC), whereas the control (using isoniazid powder) retained desired stability (> 90% at 30 days) under identical conditions. A replicate control formulation, spiked with lactose, produced statistically similar degradation profiles to that of the compounded isoniazid mixture (p > 0.05), indicating lactose to be responsible for the degradation of isoniazid. The thermoanalytical studies demonstrated an incompatibility between isoniazid and lactose (broadening and shifting of melting endotherm of isoniazid at 171.46 ºC). Conclusion: The British Pharmaceutical Codex specifies the use of isoniazid powder for compounding isoniazid mixture. This study highlights the importance for stability evaluations on all modified extemporaneous preparations in order to ensure that quality pharmaceuticals are delivered to patients. J Pharm Pract Res 2005; 35: 181-2.

show abstract

High-Performance Liquid Chromatographic Analysis of Isoniazid and Its Dosage Forms

Cited by 16 publications

References 6 publications

An evaluation of the potential use of isoniazid, acetylisoniazid and isonicotinic acid for monitoring the self‐administration of drugs.

An evaluation of the potential use of isoniazid, acetylisoniazid and isonicotinic acid for monitoring the self‐administration of drugs.

Quantification of isonicotinoyl lactosyl hydrazone in oral pharmaceutical dosage forms

Extemporaneous Isoniazid Mixture: Stability Implications

Contact Info

Product

Resources

About