Tuberculosis case notification by private practitioners in Pune, India: how well are we doing?

SETTING: Pimpri Chinchwad Municipal Corporation area, Pune, India. OBJECTIVE: To assess the proportion of private practitioners (PPs) who notified tuberculosis (TB) patients during February-April 2013 and their contribution to the overall number notified, and to determine their perceived challenges in reporting TB cases. DESIGN: Mixed-method study including an analysis of notification data, followed by in-depth interviews with PPs. Interviews were transcribed and inductive content analysis was performed to derive themes. RESULTS: Of 831 PPs, 533 (64%) participated in case notification; of these 87 (16%) notified at least one TB case during the study period. In all, 138 TB cases were notified by PPs, accounting for 20% of the total TB cases notified. Emerging themes among perceived challenges and barriers were lack of complete knowledge about TB notification, fear of a breach of patient confidentiality, lack of a simplified operational mechanism of notification, and lack of trust and coordination with the government health system. CONCLUSION: About two thirds of PPs participated in case notification and contributed significantly to the overall TB cases notified. India's national TB programme should focus on training PPs and targeted media communication campaigns, and establish alternative mechanisms for notification, such as the internet and mobile telephones, to overcome perceived barriers.

Cadre : Zone de la Corporation Municipale de Chinchwad, Pune, Inde.Objectif : Evaluer la proportion de praticiens privés (PP) qui ont déclaré des patients ayant la tuberculose (TB) entre février et avril 2013 et leur contribution au total de cas déclarés, et déterminer les défis perçus en matière de déclaration des cas de TB.Schéma : Etude reposant sur plusieurs méthodes, notamment une analyse des données de déclaration suivie d'entretiens approfondis avec des PP. Ces entretiens ont été transcrits et leur contenu a été analysé pour en dériver des thèmes.Résultats : Sur 831 PP, 533 (64%) ont participé à la notification, et parmi eux 87 (16%) ont déclaré au moins un cas de TB pendant la période d'étude. Au total, 138 cas de TB ont été déclarés par les PP, ce qui constitue 20% du total de cas de TB notifiés. Les thèmes qui ont émergé parmi les défis et contraintes perçus ont été la connaissance incomplète du système de notification de la TB, la peur d'enfreindre la confidentialité des patients, l'absence de système opérationnel simplifié de déclaration et le manque de confiance envers le système de santé gouvernemental et le manque de coordination avec ce dernier.Conclusion : Près de deux tiers des PP ont participé à la notification et ont apporté une contribution significative à l'ensemble des cas de TB déclarés. Le programme national TB devrait se concentrer sur la formation des PP, sur des campagnes de communication ciblées auprès des media et sur la mise en place de mécanismes alternatifs de notification (par exemple, par internet et par téléphone portable) pour vaincre les obstacles perçus.

Marco de referencia: La región de la Corporación Municipal de Pimpri Chinchwad de Pune, en la India.Objetivo: Evaluar la proporción de médicos del sector privado (PP) que notificaban pacientes con diagnóstico de tuberculosis (TB) durante el período del febrero a abril del 2013 y su contribución al número global de casos notificados, y determinar las dificultades que encontraron los profesionales con respecto a la notificación de casos.Método: La presente investigación adoptó un diseño de métodos mixtos, que incluyó el análisis de los datos de notificación seguido de entrevistas exhaustivas a los PP. Las entrevistas se transcribieron y se llevó a cabo un análisis de contenido de tipo inductivo con el fin de derivar los temas.Resultados: De los 831 PP, 533 participaban en la notificación (64%) y de ellos 87 notificaron como mínimo un caso de TB durante el período del estudio (16%). En total, los PP notificaron 138 casos de TB, que correspondieron al 20% de todos los casos notificados. Los temas que surgieron sobre las dificultades y las barreras a la notificación fueron la falta de un conocimiento completo sobre la notificación de la TB, el temor a infringir la confidencialidad del paciente, la carencia de un mecanismo operativo simplificado de notificación y la falta de confianza y coordinación con el sistema de salud gubernamental.Conclusión: Cerca de dos tercios de los PP participaban en la notificación y su contribución fue considerable con respecto a la totalidad de casos de TB notificados. El programa nacional contra la TB debe centrar su interés en la formación de los PP, llevar a cabo campañas dirigidas en los medios de comunicación y establecer mecanismos alternos de notificación (por ejemplo, en internet o por conducto de los teléfonos móviles), con el fin de superar las barreras percibidas en el estudio.

Stability indicating LC method for simultaneous determination of irbesartan and hydrochlorothiazide in pharmaceutical preparations.

A simple and precise stability-indicating liquid chromatography method is developed and validated for the quantitative simultaneous estimation of irbesartan (IRB) and hydrochlorothiazide (HCTZ) in combined pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with an Ace5 C(18) 25-cm analytical column using buffer-acetonitrile (70:30 v/v). The buffer used in mobile phase contains 50 mM ammonium acetate pH adjusted 5.5 with acetic acid. The instrumental settings are flow rate of 1.5 mL/min, column temperature at 30 degrees C, and detector wavelength of 235 nm using a photodiode array detector. IRB, HCTZ, and their combination drug products were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Peak homogeneity data of IRB and HCTZ is obtained using photodiode array detector. In the stressed sample chromatograms, it demonstrated the specificity of the assay method for their estimation in presence of degradation products. The described method shows excellent linearity over a range of 10-200 microg/mL for IRB and 5-100 microg/mL for HCTZ. Methylparaben was used as internal standard. The correlation coefficient for IRB and HCTZ are 0.998 and 0.999. The mean recovery values for IRB and HCTZ ranged from 100.45% to 101.25%. The limit of detection for IRB and HCTZ were 0.019 and 0.023 microg/mL, respectively, and the limit of quantification were 0.053 and 0.070 microg/mL, respectively. The proposed method was suitable for quantitative determination and stability study of IRB and HCTZ in pharmaceutical preparations and also can be used in the quality control of bulk manufacturing and pharmaceutical dosage forms.

Stability indicating LC method for the simultaneous determination of amlodipine and olmesartan in dosage form.

A simple, rapid, and precise method is developed for the quantitative simultaneous estimation of amlodipine (AM) and olmesartan (OL) in combined pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with an ACE 5 C(18) 25-cm analytical column using buffer-acetonitrile (60:40, v/v). The resolution between OL and AM was found to be more than 12. Theoretical plates for OL and AM were 6970 and 11,841, respectively. Tailing factor for OL and AM was 0.90 and 0.98, respectively. OL, AM, and combination drug product were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Peak homogeneity data of OL and AM is obtained by photodiode array detector in the stressed sample chromatograms, demonstrating the specificity of the method for their estimation in presence of degradation product. The described method shows excellent linearity over a range of 20-400 microg/mL for OL and 5-100 microg/mL for AM. The correlation coefficient for OL and AM are 0.9995 and 0.9998, respectively. The relative standard deviation for six measurements in two sets of each drug in tablets is always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and stability study of OL and AM in pharmaceutical preparations.

HPLC Method for Determination of Enantiomeric Purity of a Novel Respiratory Fluoroquinolone: WCK 1152.

A sensitive, simple, specific, precise, accurate and rugged method for determination of enantiomeric purity of S-(-)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-{4-amino-3,3-dimethylpiperidin-1-yl}-4-oxo-quinoline-3-carboxylic acid hydrochloride monohydrate, WCK 1152, a new drug substance has been developed. The method is based on prederivatization of analyte to diastereomer followed by RP-HPLC using endcapped C-18 stationary phase. Column was maintained at 30 degrees C. The UV/Vis detector was operated at 290 nm. Flow rate of the mobile phase was 1.25 ml/min. The method offers excellent separation of two enantiomers with resolution more than 4 and tailing factor less than 1.5. The method was validated for the quantification of R-(+)-enantiomer impurity, WCK 1153 in the bulk drug. Calibration curves showed excellent linearity over the concentration range of 0.1 to 1.5 mg/ml for WCK 1152 and 0.01 to 0.15 mg/ml for WCK 1153. Precision of the method was 1.13%. Limit of detection and limit of quantitation of the method for WCK 1152 were 0.0006 mg/ml and 0.0018 mg/ml and for WCK 1153 were 0.0007 mg/ml and 0.0021 mg/ml, respectively. Average recovery of the WCK 1153 in WCK 1152 was 94.4%. This method was employed in determining enantiomeric purity of clinical trial batches of WCK 1152.

Simple liquid chromatography-tandem mass spectrometry method for determination of novel anti-methicillin-resistant Staphylococcus aureus fluoroquinolone WCK 771 in human serum.

A simple, rapid, specific, precise, accurate and sensitive method for determination of WCK 771 in human serum has been developed. The method uses high performance liquid chromatography with tandem mass spectrometric detection. Sample preparation involves protein precipitation method by addition of acetonitrile. Gatifloxacin was used as internal standard. The response was found to be linear from 0.312 to 40 microg/ml of serum with correlation coefficient greater than 0.99. Limit of detection and lower limit of quantification for WCK 771 was found to be 0.078 microg/ml and 0.312 microg/ml, respectively. The intra-day precision and accuracy from analysis of quality control (QC) samples at four concentrations was in the range of 2.36-2.58% and from 96.71 to 103.2%, respectively. The inter-day precision and accuracy from analysis of quality control samples at four concentrations was in the range of 3.14-6.82% and from 96.84 to 105.76%, respectively. WCK 771 was found to be stable for 24 h at auto-injector environment. WCK 771 was also found to be stable for 2h in serum at 25+/-3 degrees C and for 3 months at -20 degrees C. Mean absolute recovery at four different concentrations was 86.92% with standard deviation of 1.79. Throughput of the method is approximately one sample every 4 min. The method was also reproduced with monkey serum. The method was employed for estimation of drug serum levels during pre-clinical and clinical trials.

Validated chiral high-performance liquid chromatography method for a novel anti-methicillin-resistant Staphylococcus aureus fluoroquinolone WCK 771.

A sensitive, simple, specific, precise, accurate and rugged method for the assay and determination of enantiomeric purity of S-(-)-9-fluoro-6,7-dihydro-8-(4-hydroxypiperidin-1-yl)-5-methyl-1-oxo-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid L-arginine salt tetrahydrate (WCK 771) in bulk drug has been developed. The method is RP-HPLC using endcapped C-18 stationary phase and chiral mobile phase. Chirality to the mobile phase was imparted with addition of beta-cyclodextrin. The UV-vis detector was operated at 290 nm. The flow rate of mobile phase was 2 ml/min. The method offers excellent separation of two enantiomers with resolution more than 2 and tailing factor less than 1.5. The method was validated for the assay of WCK 771 and quantification of R-(+)-enantiomer impurity in bulk drug. The calibration curves showed excellent linearity over the concentration range of 0.05-0.15 mg/ml for WCK 771 and 0.5-7.5 microg/ml for R-(+)-enantiomer. The precision (RSD) of the assay was 0.23%. The limit of detection and limit of quantitation of the method for WCK 771 were 0.015 and 0.06 microg/ml, respectively. The limit of detection and limit of quantitation for R-(+)-enantiomer were 0.025 and 0.09 microg/ml, respectively. The average recovery of the R-(+)-enantiomer was 100.5%. Same method was applied for the assay and determination of enantiomeric purity of WCK 771 in the intravenous formulation.

Siderophore production by fluorescent pseudomonads colonizing roots of certain crop plants.

Twelve fluorescent Pseudomonas isolates colonizing roots of four crop plants, chilli, cotton, groundnut and soybean, were examined for extracellular siderophore production in different media under iron deficient conditions. While all the organisms produced siderophores, they varied in the quantity of siderophores produced and in their preference to the medium. The siderophores were invariably hydroxamates (pyoverdine) of trihydroxamate type which formed bidentate ligands with Fe III ions.