Combined Dosage Form Research Articles

Simultaneous Determination of Estradiol Cypionate and Medroxyprogesterone Acetate Hormones in Injectable Suspension by UV Spectrophotometry Based on Least-Squares Support Vector Machine and Fuzzy Inference System: Comparison with HPLC.

The combination of estradiol cypionate (ECA) and medroxyprogesterone acetate (MPA) is used to prevent pregnancy in women. The analysis of the ECA and MPA combination reveals a challenge due to the strong overlap of the spectra of these compounds. Spectrophotometry techniques along with chemometrics methods are simple, fast, precise, and low-cost for the simultaneous determination of ECA and MPA in a combined pharmaceutical dosage form. Two developed approaches, the least-squares support vector machine (LSSVM) and fuzzy inference system (FIS), along with a spectrophotometric method were proposed to solve such a challenging overlap. Based on the cross-validation method, the regularization parameter (γ) and width of the function (σ) in the LSSVM model were optimized and the root mean square error (RMSE) values were found to be 0.3957 and 0.2839 for ECA and MDA, respectively. The mean recovery values were 99.87 and 99.63% for ECA and MDA, respectively. The FIS coupled with principal component analysis (PCA) showed mean recovery percentages equal to 99.05 and 99.50% for ECA and MDA, respectively. Also, the RMSE of both components was lower than 0.3. The analysis results of a real sample (injection suspension) using the proposed methods were compared with HPLC by a one-way analysis of variance (ANOVA) test, and no significant differences were found in the results. Intelligent methods were proposed for the simultaneous determination of ECA and MPA. The least-squares support vector machine and fuzzy inference system along with spectrophotometry were used. HPLC as a reference method was performed and compared with chemometrics methods. The benefits of the proposed approaches are that they are rapid, simple, low-cost, and accurate.

HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, AND DORAVIRINE

Objective: The objective of this study was to develop and validate an HPTLC method for the simultaneous estimation of Lamivudine, Tenofovir disoproxil fumarate, and doravirine. The method is aimed to provide reliable and efficient quantification of these drugs. Methods: The chromatographic separation of drugs was performed on aluminum plates coated with silica gel 60 F254. Samples were spotted on the plate as a 6 mm wide band using a linomat applicator and a 100 µl syringe. The mobile phase used was a mixture of ethyl acetate, methanol, and chloroform (07:02:01 % v/v/v). Densitometric scanning at 226 nm was conducted using a Deuterium lamp as the radiation source, and the data were analyzed using win CATS software. The method was validated following the ICH Guideline ICH Q2 (R1). Results: The optimized method lead to the resolution of drugs with the Rf values of doravirine (0.75±0.02), Tenofovir disoproxil fumarate (0.57±0.02), and lamivudine (0.37±0.02). Doravirine exhibited a linear range of 500-1500 ng/band with a favorable linear equation and regression coefficient of 0.999. Tenofovir disoproxil fumarate and lamivudine showed a linear range of 1500-4500 ng/band, and both compounds displayed a linear relationship with a regression coefficient of 0.997. The method's accuracy was assessed through recovery studies, and the LOD and LOQ were determined for each drug. Conclusion: The optimized HPTLC method was validated in this study, following the ICH Q2 (R1) guidelines, it demonstrates its efficacy for the quantitative analysis of Doravirine, Tenofovir disoproxil fumarate, and lamivudine. The method offers reliable quantification of these compounds in a combined dosage form and can be used for routine analysis in pharmaceuticals.

Whiteness and greenness assessment with efficacy evaluation of two UPLC systems applied for the quantification of cinnarizine and dimenhydrinate along with their toxic impurities

Fixed-dose combination of cinnarizine (CIN) and dimenhydrinate (DMH) is an effective therapy for patients diagnosed for having central and/or peripheral vestibular disorder. Comparison and evaluation of two UPLC systems for analysis of CIN and DMH along with their toxic impurities namely 1- (diphenylmethyl)piperazine (DPP) and benzophenone (BZP), respectively in pharmaceutical dosage form matrix using diode array detector (DAD) and fluorescence detector (FLD) was applied. The chromatographic conditions of UPLC systems were carried out on poroshell UPLC column C18 (3.0 × 150 mm, 1.9 μm) as a stationary phase. An isocratic elution was established using a mobile phase made of methanol and triethylamine (pH = 4.0 ± 0.02) in the ratio of (94:6, v/v). The flow rate was 0.3 mL/min using injection volume 0.5 μL through application of DAD at 256.0 nm while was done at 251.0 nm as excitation wavelength and 310.0 nm and 330.0 nm as emission wavelength for DMH and CIN in case of FLD with total run time less than 5 min. The detected linearity range for CIN was 0.5–40.0 μg/mL and that for DMH was 1.0–50.0 μg/mL using DAD while the linearity range used in FLD was 0.1–6.0 μg/mL for CIN and was 0.25–8.0 μg/mL for DMH. Different whiteness and greenness assessment tools were demonstrated to evaluate the health and safety hazard of the proposed methods such as GAPI, AGREE and RGB12 tools, as well as the chemical components risk for the mobile phase were assessed by a green specific tool named D-CHEMS-1. The two proposed UPLC systems were sustainable, green, simple, fast, and effective and were successfully used for determination of the studied drugs in their combined dosage form excluding any contribution from excipients thus, will be useful in quality control department in pharmaceutical companies.

A Review of various Analytical Methods Developed for Estimation of Paracetamol, Diclofenac sodium, and Chlorzoxazone in Single-component and Multi-component Dosage Form

Painful muco-skeletal joint disorders such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis are typically treated with a combination of paracetamol, diclofenac sodium, and chlorzoxazone. Paracetamol and diclofenac sodium are non-steroidal anti-inflammatory drugs, while chlorzoxazone is a muscle relaxant. It acts on the central nervous system and the spinal cord to reduce muscle stiffness and spasms as well as increase muscle mobility. The most commonly used pharmaceutical medicine is paracetamol, which comes in a variety of dosage forms such as injection, tablet, capsule, drops, elixirs, suspensions, and suppositories. However, due to toxicity, it may cause mortality in large dosages with extended intake. As a result, more efficient analytical approaches aimed at providing quality control of routinely used medications are required. Numerous analytical methods, both spectroscopic and chromatographic such as high-performance liquid chromatography, gas chromatography with mass spectrometry, and high-performance thin-layer chromatography have been established to estimate paracetamol diclofenac sodium and chlorzoxazone in their single-component dosage form. The simultaneous estimation of paracetamol, diclofenac sodium, and chlorzoxazone in combined dosage forms has been performed using reverse-phase high-performance liquid chromatography and high-performance thin-layer chromatography techniques. In contrast, there are very few techniques available to estimate paracetamol, diclofenac sodium, and chlorzoxazone in combination pharmaceutical dose form till date. This article is an attempt to jut out all the methods developed to estimate the above-mentioned drugs in the single or multi-component dosage form.

Development and validation of stability indicating thin‐layer chromatography method for simultaneous estimation of Benidipine hydrochloride and Telmisartan

AbstractFor the simultaneous estimation of Benidipine hydrochloride (BEN) and Telmisartan (TEL) in combined pharmaceutical dosage form, a stability‐indicating high‐performance thin‐layer chromatography (HPTLC) method has been developed and validated. It involves the use of HPTLC plates pre‐coated with silica gel 60F254 and a mobile phase comprising of Methanol: Acetonitrile (1:9 v/v). The measurements of both drugs were performed at 237 nm. The drugs were subjected to acid‐alkali hydrolysis, photolytic, thermal, and oxidation degradation. The linearity of BEN was found to be between 200–1000 ng/band (R2 = 0.9917), while for TEL, linearity was found to be between 2000 and 10000 ng/band (R2 = 0.9979). The limit of detection and limit of quantitation were found to be 3.28 and 9.94 ng/spot for BEN and 158.79 and 481.17 ng/spot for TEL. The % relative standard deviation of the precision study was determined to be less than 2%. Various system suitability parameters were determined. The Rf values of BEN and TEL were found to be 0.890 ± 0.0105 and 0.173 ± 0.0151, respectively. The resolution between BEN and TEL peak were found to be 4.48 and capacity factors were found to be 0.21 and 0.74 for BEN and TEL, respectively.

Design of Experiment-Based Green UPLC-DAD Method for the Simultaneous Determination of Indacaterol, Glycopyrronium and Mometasone in their Combined Dosage Form and Spiked Human Plasma.

Abstract Indacaterol, is an ultra-long-acting β2 agonist, glycopyrronium is a long-acting muscarinic-antagonist and mometasone is a synthetic corticosteroid. They were used recently in combination for the treatment of severe asthma symptoms and chronic obstructive pulmonary disease. In this work, it was the first time to develop a green and environment friendly ultra-performance liquid chromatographic method using design expert program for the analysis of the three drugs in their combined dosage form. Also, the method was bioanalytically validated for the analysis of the three drugs in spiked human plasma samples. The method was linear in range from 0.50 to 100.0 μg mL−1 for indacaterol and mometasone and from 1.0 to 150.0 μg mL−1 for glycopyrronium. It showed high accuracy where, the % recovery for indacaterol, glycopyrronium and mometasone in plasma were ranged from 94.27 to 97.86%, 96.43 to 98.75% and 96.86 to 98.43%, respectively. Also, it was precise where, the % relative standard deviation for the inter-day precision was ranged from 2.571 to 3.484%, 3.180 to 4.123% and 3.150 to 3.984% and the intra-day precision was ranged from 2.351 to 3.125%, 2.512 to 3.544% and 2.961 to 3.983% for indacaterol, glycopyrronium and mometasone, respectively. The limit of detection and the limit of quantification for indacaterol and mometasone were 0.03 and 0.10 μg mL−1 while for glycopyrronium, they were 0.16 and 0.50 μg mL−1. Highlights

Analytical Method Development and Validation for Estimation of Spironolactone and Hydrochlorothiazide in Bulk and Tablet Dosage form by High Performance Liquid Chromatography

Analytical Method Development and Validation for Spironolactone and Hydrochlorothiazide in bulk and Combined Dosage Form by RP-HPLC. New method was established for simultaneous estimation of Spironolactone and Hydrochlorothiazideby RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Spironolactone and Hydrochlorothiazideby using Inertsil C18 (4.6mm ×250mm, 5µm particle size), flow rate was 1.0ml/min, mobile phase ratio was (55:45% v/v) Methanol: Phosphate buffer pH 4.8 (pH was adjusted with ortho phosphoricacid), detection wavelength was 282nm. The instrument used was WATERS Alliance 2695 separation module, Software: Empower 2, 996 PDA detector. The retention times were found to be 1.688mins and 3.282mins. The %purity of Spironolactone and Hydrochlorothiazidewas found to be 99.86%. The system suitability parameters for Spironolactone and Hydrochlorothiazidesuch as theoretical plates and tailing factor were found to be 7586, 1.69 and 6235 and 1.58, the resolution were found to be 10.85. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study ofSpironolactone and Hydrochlorothiazidewas found in concentration range of 100µg-500µg and 30µg - 70µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.112% and 100.16%, %RSD for repeatability was 0.1702 and 0.043 respectively. The precision study was precise, robust, and repeatable. The LOD value was found to be 2.1µg/ml and 1.28µg/ml, and LOQ value was 6.3µg/ml and 3.84µg/ml for Spironolactone and Hydrochlorothiaziderespectively. Hence the suggested RP-HPLC method can be used for routine analysis of Spironolactone and Hydrochlorothiazide in API and Pharmaceutical dosage form.

Development and validation of a stability indicating green analytical method for the simultaneous estimation of l-glutathione, n-acetyl l-cysteine and Vitamin C in marketed formulation using UV–visible spectroscopy

BackgroundAn efficient ultraviolet spectrophotometric method has been devised for the simultaneous analysis of l-glutathione, n-acetyl l-cysteine and Vitamin C in combined tablet dosage forms. This method is characterized by its simplicity, rapidity, precision, accuracy and cost-effectiveness. It employs the simultaneous equation method to determine the concentrations of l-glutathione, n-acetyl l-cysteine and Vitamin C.ResultsThe concentration range of 50–250 μg/mL for l-glutathione, 15–75 μg/mL for n-acetyl l-cysteine and 2–10 μg/mL for Vitamin C demonstrated linearity in this study. The simultaneous equation method was employed to determine the drug concentrations. The average recovery rates were found to be 99.94 ± 0.61% for l-glutathione, 100.90 ± 0.96 for n-acetyl l-cysteine and 99.81 ± 0.58% for Vitamin C. Stability studies were performed under various stress conditions.ConclusionThe method employed in this study was observed to possess qualities of simplicity, accuracy and precision, making it suitable for the simultaneous determination of l-glutathione, n-acetyl l-cysteine and Vitamin C in pharmaceutical tablet dosage forms. The analysis results were statistically validated and supported by recovery studies and stability studies, further enhancing the credibility of the method.

Simultaneous Estimation of Artemether and Lumefantrine in Tablet Formulation by UV-Visible Spectroscopy using Simultaneous Equation Method

In the present work, a simple, accurate and precise method has been developed and validated for the simultaneous estimation of antimalarial agents, Artemether & Lumefantrine and in their combined dosage form i.e. tablets by UV Spectrophotometric Method. It employs estimation of drugs by Simultaneous Equation Method (SEM) using 250 nm and 305 nm in Chloroform as λmax values of Artemether and Lumefantrine respectively. Both drugs obey Beer-Lamberts law in the concentration range of 4.5 μg/ml to 82.5 μg/ml. Validation of the proposed methods was carried out for its precision, linearity and limit of detection according to specifications. The recovery studies ascertained accuracy and reproducibility. The method was applied successfully for the estimation of Artemether and Lumefantrine in tablet dosage form without the interference of common excipients

Development and validation of analytical method for determination of valproate and valproic acid in bulk and pharmaceutical dosage form by using RP-HPLC

A New RP-HPLC Method for the Simultaneous Estimation of Valproate and Valproic acid in bulk and its Pure and Pharmaceutical Dosage Form as per ICH Guidelines. The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for simultaneous estimation of Valproate and Valproic acid in pure and combined dosage form. Chromatographic separation was done using Symmetry ODS C18 column having dimension of 4.6×250mm having particle size of 5.0µm, with mobile phase consisting of Acetonitrile: Methanol in the ratio 65:45v/v, flow rate was adjusted to 1ml/min and detection wavelength at 256nm. The retention times of Valproate and Valproic acid was found to be 2.256 and 5.427 mins. The proposed method has been validated for accuracy, precision, linearity; robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Valproate and Valproic acid was found in range of 6µg-14µg and 18µg-42µg and correlation coefficient was found to be 0.999 and 0.999% RSD for intermediate precision was found to be 0.5 and 0.3, for repeatability was 0.4 and 0.1, % mean recovery for Valproate and Valproic acid was found to be 101.326% and 100.501% respectively. The method was found to be robust even by change in the mobile phase ±2% and in more and less flow conditions. The developed method can be successfully employed for the routine analysis of Valproate and Valproic acid in bulk and Pharmaceutical dosage forms.

METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF PREGABALIN AND ETORICOXIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UV-VISIBLE SPECTROSCOPY

A simple, accurate, precise and economical method has been developed for the simultaneous estimation of pregabalin and etoricoxib in combined dosage form by using double point standardization method. Methanol is used as the solvent and chromogenic agent added was bromocresol green. Bromocresol green is only reactive with pregabalin form a green colour ion pair complex. l max of pregabalin and etoricoxib was at 618 nm and 235 nm, respectively. The method was found to be linear in the range of 6-22 µg mL-1 for pregabalin and 4.8-17.6 µg mL-1 for etoricoxib. Validation parameters was performed and method was found to be linear, accurate, precise, rugged and robust.

Simultaneous Analysis of Cilnidipine and Nebivolol by Absorbance Correction Method and Q Absorption Ratio Method

Two novel UV spectrophotometric methods have been developed for the simultaneous estimation of cilnidipine (CIL) and nebivolol hydrochloride (NBV) in combined dosage form. Method I was based on absorbance correction principle while method II was Q absorption ratio method. For absorbance correction method, λmax of CIL 242.6nm was chosen as λ1, as NBV shows nil absorbance at this wavelength and 280.6nm, the λmaxof NBV was chosen as λ2 , as both the drugs showed satisfactory absorbance at this wavelength. Beer’s law was obeyed in the concentration range of 4-48μg/mL and 4-100μg/mL for cilnidipine and nebivolol hydrochloride respectively with correlation coefficients (r2) greater than 0.990. For Q absorption ratio method, 275nm (Isosbestic point) and 280.6nm (λmax of NBV) were chosen as the two wavelengths for analysis. Beer’s law was obeyed in the concentration range of 4-48μg/mL and 4-100μg/mL for cilnidipine and nebivolol hydrochloride, respectively with correlation coefficients (r2) greater than 0.990. The developed methods were validated as per ICH guidelines. The % assays of cilnidipine and nebivolol hydrochloride in tablet dosage form were found to be 97% and 102%, respectively by absorbance correction method and 95% and 105% by Q absorption ratio method, which were within acceptance limits. The developed methods can thus serve as powerful quality control tools for simultaneous determination of cilnidipine and nebivolol hydrochloride in bulk and in combined dosage form.

Green versatile micellar electrokinetic chromatographic method for determination of six antimicrobial and anti-inflammatory drugs in combined dosage forms

AbstractA fast reliable micellar electrokinetic methodology was investigated for the concurrent quantitation of six antimicrobial and anti-inflammatory drugs, namely, ciprofloxacin, dexamethasone, metronidazole, ornidazole, spiramycin and tinidazole. The method has the merits of rapidity, precision, and sensitivity. The separation was carried out in less than 7 min by applying a basic background electrolyte consisting of 25 mM disodium tetraborate buffer, pH 9 containing 50 mM SDS at 25 kV using photodiode array detector at 230 and 315 nm. The internal standard used during analysis was cromolyn sodium and validation was carried out following ICH guidelines. The proposed method showed linear response over the range from 0.5 to 10.0 μg mL−1 reaching limits of detection and limits of quantitation in the ranges of 0.09–0.2 μg mL−1 and 0. 27–0.6 respectively. The method's greenness was estimated using the GAPI tool where excellent greenness was concluded. Co-formulated or single-ingredient commercial preparations were investigated and the results were statistically evaluated.

Area under the curve and ratio difference spectrophotometric methods with evaluation of the greenness for simultaneous determination of olmesartan medoxomil and metoprolol succinate

The aim of this study is to develop and validate two simple spectrophotometric methods for simultaneous determination of metoprolol succinate (MET) and olmesartan medoxomil (OLM) in tablet form. Method (I) was area under the curve (AUC) method. This approach involved the measuring of the area over a variety of wavelengths. Two wavelength ranges; 213–230 nm and 244–266 nm were chosen for determination of MET and OLM, respectively. Method (II) was ratio difference spectrophotometricmethod. For determination of MET, the ratio spectra were generated using 15 μg/mL OLM as a divisor then the peak to trough amplitudes between 221 nm and 245 nm were displayed versus the corresponding concentrations of MET. For determination of OLM, the peak-to-peak amplitudes between 247 and 293 nm were chosen and found to be directly proportional to OLM concentrations using 15 μg/mL MET as a divisor. The linearity ranges were 2–30 μg/mL and 2–25 μg/mL for MET and OLM, respectively. The assay results showed good mean %recovery ± SD as well as good agreement with that of the reported method. The developed methods were validated according to ICH guidelines. The developed methods are accurate, precise, eco-friendly and could be applied successfully to estimate OLM and MET in their combined dosage form.

Mathematical processing of absorption as green smart spectrophotometric methods for concurrent assay of hepatitis C antiviral drugs, Sofosbuvir and Simeprevir: application to combined pharmaceutical dosage forms and evaluation of the method greenness

The present work was developed to create three rapid, simple, eco-friendly, cheap spectrophotometric methods for concurrent assay of Sofosbuvir (SOF) and Simeprevir (SMV) in their pure, laboratory prepared mixture and pharmaceutical dosage form with high degree of accuracy and precision. Three methods were developed including iso-absorptive point, ratio subtraction and dual wavelength. The linear range of the proposed methods was 3.0–50.0 and 2.0–50.0 µg mL−1 for SMV and SOF, respectively. The proposed methods were validated according to ICH guidelines in terms of linearity, accuracy, precision, limit of detection and limit of quantitation. The proposed approach is highly simple and the procedure is environmentally green making it suitable for the drug analysis in routine works.

RP-HPLC method for estimation of miglitol and metformin hydrochloride in pharmaceutical formulation

A simple, rapid and sensitive RP-HPLC method was developed for the quantitative determination of metformin hydrochloride and miglitol in combined tablet dosage form. The chromatographic analysis was carried out on Phenomenex Gemini C18 (250 x 4.6 mm, 5 μm) with mobile phase containing methanol: TEA buffer (50:50 v/v). The flow rate of mobile phase was 1.0 mL/min and effluents were monitored at 272 nm. The retention times of miglitol and metformin hydrochloride were 2.121 min and 3.643 min, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity and robustness.The method was found to simple, rapid and sensitive and was successfully applied to the estimation of metformin hydrochloride and miglitol in combined dosage form.

Reverse Phase High Performance Liquid Chromatography for Validation of Epinastine Hydrochloride in Bulk and Pharmaceutical Dosage Form

The validation method of epinastine hydrochloride from combined dosage form i.e. eye drops was described by high performance liquid chromatography method with separation of drugs on Water symmetry RP18 (150 x 4.6 mm i.d.) and 5 µ particle size. A mixture of buffer and acetonitrile (73:27 % (v/v)) was constituted as mobile phase. The chromatograms were studied at 220 nm as wavelength. The mobile phase was also used as a diluent. A validated of method was studied for linear regression, accuracy, method as well as system precision. The robustness study was done for change in wavelength, mobile phase composition and flow rate as per ICH guidelines. The method has been successfully used to analyze epinastine hydrochloride from dosage form i.e. eye drops.

Development and Validation of HPLC Method for Estimation of Some Active Analytes in Combined Dosage form an Application to In-vitro Dissolution Studies

This paper describes a new, simple, accurate and economical method of development and validation of HPLC method for the assessment of dicyclomine hydrochloride with omeprazol magnesium combine dosage form. The method development trial was carried out initially using C8 (100×0.46×3.5 μm) and C18 GraceSmart (250×4.6×5 μm) as stationary phase and acetate buffer (pH 4.5) and methanol as mobile phase in proportion 60:40v/v. The optimized conditions of factors were sample size 50 μL and wavelength (λmax) 215 nm. The developed method was then applied to in-vitro dissolution studies for the dicyclomine hydrochloride and omeprazole magnesium. As per ICH guidelines, stability testing was done. The estimated method can be used to analyze the pharma industries’ products.

New analytical LC–MS/MS method for fluconazole and ivermectin estimation in combined pharmaceutical dosage form: development and validation

BackgroundFluconazole, an antifungal drug, prevents fungi growth by inhibiting the formation of a protective covering. Ivermectin has several biological activities, such as antibacterial, antiviral, and anti-cancer characteristics, and offers various therapeutic outcomes. There are several commercial products containing these two drugs. Therefore, developing a method that can allow the simultaneous estimation of Fluconazole and ivermectin is inevitable to monitor them in commercial dosage forms. The hyphenated methodology that combines spectroscopic and chromatographic techniques is gaining high interest in the pharmaceutical industry. Consequently, the objective of present research work was to investigate robust and sensitive LC–MS/MS avenue for simultaneous determination of Fluconazole and ivermectin in pure material and combined dosage form.ResultsThe simultaneous quantification of Fluconazole and ivermectin in tablet dosage form has been developed and validated using a straightforward, sensitive, practical, and repeatable LC–MS/MS approach. The separation was performed using a C18 (150 × 4.6 mm) column, injection volume of 10 µL, and elution with acetonitrile: formic acid at a ratio of 70:30, with the column temperature at 30 °C, and a flow rate of 4.0 mL/min. The retention times of Ivermectin and Fluconazole were 1.10 min and 1.05 min, respectively. The calibration curves for Fluconazole and ivermectin demonstrated significant linearities indicated by the correlation coefficients (r2 = 0.999 and r2 = 0.997) and precision (% R.S.D. of 1.58 and 1.13). The linear correlation between peak area and concentration allowed high percentage recoveries of 98.5%–99.4% and 97.8%–99.3% for Fluconazole and Ivermectin, respectively. The L.O.D.s for Fluconazole and ivermectin were found to be 0.0034 and 0.074 g/mL, respectively. The L.O.Q.s for Fluconazole and ivermectin were 0.010 and 0.225 g/mL, respectively.ConclusionAll the analytical parameters were identified and found to be within the acceptable range set forth by the ICH guidelines, demonstrating the devised method's acceptability in the simultaneous detection and estimation of Fluconazole and ivermectin in the commercial dosage forms.

Analytical method development and validation of rifaximin and ornidazole in bulk and combined tablet dosage form as per ICH guidelines

Analytical method development and validation of rifaximin and ornidazole in bulk and combined tablet dosage form as per ICH guidelines