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T. Venkatachalam ¹, K. G. Lalitha ²

Affiliations
1 Department of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, B. Komarapalayam - 638 183, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, ULTRA College of Pharmacy, Madurai - 625 020, Tamil Nadu, IN

Abstract

A simple, accurate and precise densitometry method for the simultaneous estimation melatonin (MEL) and zolpidem (ZOL) in pharmaceutical dosage forms has been developed and validated. Separation of drugs was carried out using toluene: n-butanol:glacial acetic acid:water (1:4:2:2v/v/v/v) as mobile phase on precoated Silica Gel 60F₂₅₄ plates. The densitometry evaluation of spot was carried out at 254 nm. The R_f value for MEL and ZOL were found to be 0.87±0.01 and 0.59±0.01 respectively. The method was validated with respect to linearity, accuracy, precision and robustness as per the International Conference on Harmonization (ICH) guidelines. The drug response with respect to peak area was linear over the concentration range 150-900 ng/spot and 250-1500 ng/spot for MEL and ZOL respectively, limit of detection and limit of quantitation were found to be 14.96 ng/spot and 45.60 ng/spot for MEL and 19.53 ng/spot and 59.24 ng/spot for ZOL. The percentage recovery of MEL and ZOL were found be 99.04-99.35% and 98.11-98.77% respectively. The % RSD values for (intra-day RSD 0.26-0.56% and inter-day RSD 0.36-0.78 %for MEL and intraday RSD 0.18-0.31% and inter day 0.23-0.31% for ZOL). It was observed that the proposed HPTLC method could be used for efcient analysis and monitoring of the MEL and ZOL in combined tablet dosage forms.

Keywords

Melatonin, Zolpidem, HPTLC, Validation.

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Anitha Kumari ¹, K. G. Lalitha ¹, T. Venkatachalam ², P. Kalaiselvi ², M. G. Sethuraman ³

Affiliations
1 Ultra College of Pharmacy, Madurai – 625 020, IN
2 Annai JKK Sampoorani Ammal College of Pharmacy, B. Komarapalayam - 638 183, IN
3 Gandhigram Rural University, Gandhigram – 624 302, IN

Abstract

Pavonia zeylanica Linn. (Family: Malvaceae) commonly known as Sittramutti (Tamil) is an herb distributed in the tropical and sub-tropical regions of the world, and also found abundantly in India. It has considerable reputation as a potent medicament in the treatment of various ailments such as inflammation, fever and toothache. The antiinflammatory effect of the leaves of P. zeylanica, was evaluated using carrageenan induced paw oedema and cotton pellet induced granuloma (chronic) in rat models. The extract was also evaluated by hot plate and acetic acid induced abdominal constriction assay to assess analgesic activity. The alcoholic extract of P. zeylanica (AEPZ) exhibited significant (P < 0.01) anti-inflammatory effect at the dose 50, 100 and 200 mg/kg. Maximum inhibition 46.16 % was noted at the dose of 200 mg/kg after 3 h of drug treatment in carrageenan induced paw oedema, whereas the Indomethacin 10 mg/kg (standard drug) produced 65.38 % of inhibition. In the chronic model (cotton pellet induced granuloma) the AEPZ (200 mg/kg) and standard drug showed decreased formation of granuloma tissue by 40.30 % and 67.20 % (P < 0.01) respectively. The extract also found to possess antinociceptive activity against acetic acidinduced writhing and hot plate reaction in mice. In acetic acid-induced abdominal constriction assay ) the AEPZ (200 mg/kg) and standard drug aspirin showed reduction in abdominal constriction by 47.64% and 62.38% (P < 0.01) respectively.Thus, the present study revealed that the alcoholic extract of P. zeylanica exhibited significant antinociceptive and anti-inflammatory activity in the tested models.

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T. Venkatachalam ¹, V. Kishor Kumar ¹, P. Satheesh Kumar ¹, P. Kalaiselvi ¹, M. Chitra ¹, N. Senthil Kumar ¹

Affiliations
1 Department of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, B. Komarapalayam, Tamil Nadu, IN

Abstract

In this paper, in vitro antioxidant and antimicrobial activities of ethyl acetate extract of Evodia lunu-ankenda (Gaertn) Merr. bark was determined by four methods Diphenylpicrylhydrazyl (DPPH), Nitric Oxide, Super oxide disumatase, Hydrogen peroxide (H₂O₂) and by agar disc diffusion methods. The crude ethyl acetate extract of Evodia lunuankenda bark inhibited the growth of both gram positive bacteria (Bacillus substilis, Staphylococcus aureus and micrococcus luters) and gram negative bacteria (Escharichia coil, Pseudomonas aeruglinosa and Salmonella typhlmurium) and also the crude ethyl acetate extract of Evodia lunuankenda bark inhibited the growth of fungi (candida albicans and Aspergillus niger). The ethyl acetate extract of Evodia lunuankenda bark showed dose dependent increase in reducing anti oxidant power that was comparable to standards. Antibacterial activity, highest concentration of ethyl acetate extract (5mg/ml) having good activity against gram positive and gram negative organisms as compared with the reference Ciprofloxacin. Antifungal activity, highest concentration of extract (5mg/ml) having good activity as compared with the reference Amphotericin-B. It can be concluded that the plant posses potent antioxidant and antimicrobial activity, responsible of the secondary metabolites like flavonoids, saponins, are likely observed for the plants.

Keywords

Antioxidant Activity, Antimicrobial Activity, Agar Disc Diffusion Method, Evodia lunu-Ankenda (Gaertn) Merr. Bark.

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P. Kalai Selvi ¹, T. Venkatachalam ¹, V. Kishor Kumar ¹, K. G. Lalitha ²

Affiliations
1 Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, IN
2 Department of Pharmaceutical Chemistry, Ultra College of Pharmacy, Madurai-625020, Tamil Nadu, IN

Abstract

A Simple and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative determination of Diacerein in bulk and its pharmaceutical formulations. Chromatographic separation was performed by using column XDB C₈ (4.6×150 mm, 5 μm) with a mobile phase comprising of a mixture of phosphate buffer and Acetonitrile (50:50,v/v) and pH adjusted to 3 with orthophosphoric acid, at a flow rate of 0.8 ml/min with detection at 254 nm. Separation was completed in less than 10 min. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, ruggedness and robustness. Linearity of Diacerein was found to be in the range of 10-100 μg/ml and correlation coefficient was found to be 0.999. The retention time of Diacerein was 3.3 min;the separation was performed at an ambient temperature. The limit of Detection and limit of quantitation for Diacerein was found to be 3.6 and 9.95 (S/N ratio). There was no significant difference in the intraday and inter day analysis of Diacerein determined for five different concentrations using this method. The RSD value 0.3% indicates a high precision of the analytical method.

Keywords

The Proposed Method was Simple, Sensitive, Precise, Accurate and Useful for Routine Quality Control Analysis.

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T. Venkatachalam ¹, V. Kishor Kumar ¹, P. Kalai Selvi ¹, R. Srinivasan ¹, R. Mariammal ², K. G. Lalitha ³

Affiliations
1 JKKMMRF College of Pharmacy, B. Komarapalayam, IN
2 ROVER College of Pharmacy, Perambalur, IN
3 ULTRA College of Pharmacy, Madurai, IN

Abstract

Simple, sensitive, and specific spectrophotometric methods were developed and validated for quantitation of Metoprolol succinate and Hydrochlorthiazide in tablet dosage form. A new analytical method was developed based on the simultaneous estimation of drugs in a binary mixture without previous separation. In simultaneous equation method, Metoprolol succinate and Hydrochlorthiazide were determined by using their absorptivity values at wavelength maxima, viz., 222 nm and 272 nm. The standard deviation value for the different validation parameters was found to be between 0.094 and 1.01 for simultaneous equation method. This method is simple, accurate, rapid, and they require no preliminary separation and can therefore be used for routine analysis of both drugs in quality control laboratories.

Keywords

Spectrophotometric, Metoprolol Succinate, Hydrochlorthiazide, Simultaneous Equation Method.

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P. Kalaiselvi ¹, R. Vijay Amirtharaj ¹, T. Venkatachalam ¹, N. Senthil Kumar ¹

Affiliations
1 JKKMMRF College of Pharmacy, Komarapalayam-638183, Tamil Nadu, IN

Abstract

A simple, precise, accurate and rapid HPTLC method has been developed, and validated for the determination of Pioglitazone HCl and Telmisartan simultaneously, in combined dosage form (15 mg and 20 mg). Pioglitazone HCl and Telmisartan was chromatographed on silica Gel 60F₂₅₄ TLC plate using Toluene:ethyl acetate: methanol (7:2:1 v/v) was used as the mobile phase. The R_f value of Pioglitazone HCl and Telmisartan was 0.56±0.04 and 0.23±0.02 and scanned at 254 nm using camag TLC scanner 3. The applicability of the method for simultaneous determinations of Pioglitazone HCl and Telmisartan was verified by the determination of these compounds in marketed tablets. Results of the analysis were validated statistically, and by recovery studies (99.47-101.36% and 99.40-102.37%). The recovery and RSD values were with in limits given in ICH guidelines, method developments indicates that the suitability of proposed for the routine determination of these compounds in tablets. The validation parameters; linearity the range 30-150 ng/spot and 40-200 ng/spot (r=0.9995 and r=0.9996) sensitivity. The limit of detection was found to be 15 ng/spot and 20 ng/spot. The limit of quantification was found to be 45 ng/spot and 60 ng/spot respectively. The accuracy ((99.88% and 99.33%) and reproducibility were found to satisfactory. The proposed method can be successfully used to determine the drug contents on marketed formulation.

Keywords

HPTLC, Pioglitazone HCl, Telmisartan, Methanol, Validation.

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T. Venkatachalam ¹, S. Narendiran ¹, P. Kalai Selvi ¹, P. Dheen Kumar ²

Affiliations
1 Dept. of Pharmaceutical Chemistry, JKKMMRF College of Pharmacy, Komara Palayam-638183, Tamil Nadu, IN
2 Dept. of Pharmaceutical Chemistry, Maharaji College of Pharmacy, Chennai-600090, Tamil Nadu, IN

Abstract

A simple, precise, accurate and rapid HPLC method has been developed, and validated for the determination of ofloxacin and satranidazole simultaneously, in combined dosage form. Acetonitrile and ammonium di-hydrogen orthophosphate buffer with ph 7.0 (50%:50%)is used as the mobile phase, 300 is the detection wavelength for this study. The applicability of the method for simultaneous determinations of oflaxacin and satranidazole was verified by the determination of these compounds in marketed tablets .Results of the analysis were validated statistically, and by recovery studies (99.43-101.28%). The recovery and RSD values with in limits given in ICH guidelines method developments indicates that the suitability of proposed for the routine determination of the these compounds in tablets .the validation parameters; linearity (r=9999) sensitivity (LOD (1.0-1.5×10^-4), LOQ (3.0-4.5×10^-4) accuracy (99.43-101.28%) and reproducibility were found to satisfactory. The proposed method can be successfully used to determine the drug contents of marketed formulation.

Keywords

RP-HPLC, Oflaxacin, Satranidazole, Validation.

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